Sales Compensation Administration - Analyst / Manager

The Sales Comp Administration - Analyst / Manager role is to support the Sales Operations Incentive Compensation team for all business units / sales forces in administering Sales Incentive Compensation Programs which includes ad hoc analysis and reporting. As such the Sales Comp Administration - Analyst / Manager will be responsible for all sales compensation administration aspects including the maintenance of all sales force reference data, variable pay information, and compensation plan information within the compensation systems (TrueComp) and Incentive Compensation platforms. Additionally they will work with the Business Unit Comp Managers to collect plan design information and be responsible for the oversight of development and testing of compensation plans and rules in TrueComp. He/She will support and maintain the monthly sales and goal validation process, which requires critical thinking and problem solving skills. Candidate will also manage department SOPs, prepare department activity timelines, maintain documentation for various purposes such as program policies, eligibility, auditing & OCM purposes. Candidate will also support multiple supplemental incentive programs including the management of processing guidelines to ensure accuracy and consistency including application design & management. He/She will also help manage awards program documentation, criteria, history, inventory, etc. He/She will maintain content on IC Portals and facilitate process/data management with vendors. Candidate must have SQL skills for querying data and a basic understanding of sales compensation philosophy. Candidate will proactively coordinate with internal partners to ensure data accuracy, optimize operational processes and meet aggressive timelines. Provide adhoc support and analysis, including running queries and producing reports (using Access, Brio, Toad or other sql tool). Strong technical, stakeholder manager and communication skills are required.

Key Responsibilities:

- Primarily responsible for the administration and management of all sales incentive compensation administration deliverables including oversight of system configuration for IC plans, reference data (e.g. eligibility), timely and accurate payout processing, supplemental incentive programs, reporting and reference data management for all brands.

- Partner with Sales Operations Managers, Vendors and/or the Information Technology team to define data and reporting needs in support of the IC payout process and supplemental incentive programs.

- Collaborate with various internal and external stakeholders to ensure fairness and consistency in the implementation of and adherence to program policies.

- Communicate with field sales management in support of the sales incentive program payout process and provide supplemental incentive programs summaries.

- Development communication and reporting materials to support IC administration activities and status reports.

• Manage and track the Validation program and assigned validation projects and ensure target
• timelines are met and/or issues are communicated / escalated effectively and consistently.
• Generate, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents.
• Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs, SIP, CV) for equipment.
• Manage protocol execution, perform data review and manage deviation resolution.
• Oversight and management of validation contract resources including work prioritization, execution and contractor budget.
• Strong understanding of commercial production environment and requirements.
• Evaluate and audit the current validated status of equipment/systems temperature mapping and cleaning validation program.
• Proven ability to make suggestions for improvements as well as ensure programs are operating in a compliant and validated state.
• Present validation packages as required for audits and/or regulatory inspections.
• Perform role of subject matter expert and assess change control and discrepancy events for to validated systems.
• Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).
• Participate in cross-functional team meetings and where required, lead/facilitate meeting.
• All employees with jobs that require access to the Warehouse must be able to pass the
• Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Ensures there will be integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within their functional area.

This positon may be filled at an Associate Contract Manager or Contract Manager  level.

The Managed Care Contracts Group manages the contracting process from development of an account-centric contract strategy through execution of an agreement. The Associate Contract Manager, Managed Care Contracts develops, drafts, analyzes, negotiates and gains the necessary approvals for the assigned managed care accounts and contracts.

• Works closely with Contract Managers and other internal partners in reviewing customer contract needs, requirements, etc. in alignment with GNE contracting strategies, business objectives, and other contract conditions
• Conducts various analyses and modeling of appropriate contract terms and reviews with key internal partners/stakeholders
• Obtains all appropriate and required internal reviews and approvals for contract terms and provisions
• Develops language and drafts contracts and related documentation
• Responds to various partner/stakeholder questions, inquiries, requests for clarification, etc. regarding contracts and terms/conditions or other items
• Ensures execution of approved and finalized customer contracts; including timely and accurate hand-off to other internal partners/stakeholders
• Monitors existing customer contracts using approved performance methodologies, tools, etc.; includes identifying and recommending opportunities for improvement
• Ensures all contract data and information is appropriately entered into relevant systems/databases
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Business travel, by air or car, may be required for regular internal and external business meetings

The AE&O Senior Project Manager scopes, plans and manages local, regional and global IT projects consisting of one or more delivery streams. He/she works with solution owners and project sponsors within AE&O (Architecture, Engineering & Operations) and SP&A (Shared Platforms & Applications).

As part of a team of project management professionals he/she reports to one of the Team Leads of Project Management within AE&O Project & Portfolio Management and is supported by portfolio analysts of the AE&O PMO and SP&A PMO (if applicable).

The Senior Project Manager is responsible for scoping, planning, managing and controlling global IT projects and reporting in a timely, accurate and transparent manner following standardized methods to allow accurate portfolio management and project execution control within AE&O and SP&A.

The senior project manager works closely with a responsible portfolio analyst from the PMO in AE&O (or SP&A) to ensure timely and accurate project reporting on project scope, schedule, cost and resources, as well as project risks, issues, action items, and dependencies.

In addition the senior project manager needs to collaborate closely with the Finance, Quality & Procurement departments as required. Also the involvement of other Pharma IT areas outside of AE&O and SP&A (as internal project workforce) might be required (e.g. Roche’s Shared Service Center in Warsaw).

Major Responsibilities include:

• Project Scope Management - Formulating and defining scope and objectives of the project in collaboration with the responsible Solution Owner and ensuring communication of project goals, schedule baselines, and business direction to all identified stakeholders
• Project Stakeholder / Communication Management - Identifying all relevant project stakeholders and establishing and implementing an appropriate communication plan to manage their requirements
• Project Delivery Primarily - Delivering the project on time, on approved (baseline) budget, within quality limits, and with the expected benefits, as defined at project entry and project baseline gates and through controlled and documented change management throughout project delivery, as needed
• Project Risk, Assumption, Issue and Dependency (RAID) Management - Actively managing risks, assumptions, issues and dependencies (RAID) by carefully assessing potential impacts in collaboration with the respective project teams and proposing appropriate mitigation actions. Is also responsible for identifying, actively managing and integrating with any dependent projects or activities.
• Project Planning, Tracking, Control & Reporting - Creating baseline project schedules and tracking the completion of project deliverables, tasks, activities and milestones. Providing accurate, timely and fit for purpose project status reports using established norms and reporting tools of the portfolio
• Team Building & Leadership - Organizing and supervising the appropriate involvement of project resources and actively managing and addressing the resolution of conflicts within the project team.
• Compliance – Directly accountable for ensuring compliance with project management, portfolio management and CSV policies, guidelines, process tools and reporting standards of the portfolio. These norms will include all system qualification/validation state documentation, project documentation and resource forecasting/tracking, financial forecasting/tracking and governance procedures of the portfolio for the specific projects assigned

The DMPK group is dedicated to enabling the discovery, developmentand commercialization of safe and effective medicines by elucidating theabsorption, distribution, metabolism, excretion and pharmacokinetic propertiesof small molecule drug candidates. We accomplish this through the applicationof state of the art technologies and sciences of bioanalysis, drug metabolism,drug transport and pharmacokinetics. The DMPK group works in close partnershipwith disciplines such as medicinal chemistry, pharmacology, toxicology,pharmaceutical sciences, clinical pharmacology and regulatory to optimizeleads, select clinical candidates, conduct preclinical development studies,support clinical evaluation and contribute to IND and NDA filings.

We are seeking a candidate to support both in vitro and in silicoADME.  The candidate will work with anestablished team on various in vitro assays and will collaborate with otherscientists in the group to perform hypothesis-driven studies to address ADMEquestions.  On the in silico side, thecandidate will apply ADME models to support projects and maximize the value of existingADME data. They will work at the intersection of modeling ideas, modelgeneration and experimental investigation to support/build SAR and meet projectneed.  A key part of the role will becontinuing education in the department on use of predictive DMPK and championinguse of in silico tools. The candidate will be a highly effective and energizingcollaborator and will work scientists from multiple disciplines including computationaland medicinal chemistry, safety assessment and pharmaceutical sciences.

This position may be filled at a Product Manager or Sr. Product Manager 

Senior Product Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics for the assigned managed care segments in the U.S. and related territories. Managed Care Marketing directly supports Genentech’s business by ensuring managed care marketing strategies, plans and tactics enable business, financial and operational goals, targets and objectives to be met or exceeded across managed care segments within the U.S. Senior Product Managers act as a primary liaison to managed care account management in the assigned managed care segments and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned.
 

• Plays a key role in development and delivery of the Genentech & Product Value Proposition
• Stays abreast of and continuously develops his/her knowledge regarding internal and external business developments and drivers. Includes in-depth knowledge of the current and evolving managed care landscape and its implications for Genentech -  formulary positioning, reimbursement, access and overall market share
• Responsible for educating internal partners and stakeholders regarding the managed care landscape in the U.S. and related territories and implications of such to current, medium- and longer-term managed care marketing strategies, plans and objectives for assigned segments
• Reviews and assesses cross-functional business strategies, plans and tactics; using to determine and recommend managed care marketing strategies, plans and activities that support optimal formulary  positioning, reimbursement, access and overall market share
• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall financial results
• Responsible for expertly creating and managing 3-year and 1-year managed care marketing strategies, plans, and tactics for assigned managed care segments
• Works closely with cross-functional teams to align therapeutic area and managed care marketing strategies, plans and tactics with pricing, reimbursement, contracting, distribution and other relevant business, financial and operational strategies, plans and objectives 
• Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans
• Collects customer insights through advisory boards, strategic councils and focus groups, develops key portfolio resources for MCCO (Managed Care & Customer Operations) field such as disease state/product marketing materials, B2B strategic talking points, eMarketing planning and execution, and training the MCCO field in all such tools
• Where applicable, supports product launches. May participate in the development and implementation of managed care marketing launch plans. Includes contributing managed care marketing expertise to other aspects of the overall launch plan and helping ensure launch plan excellence
• Works with cross-functional groups to ensure a seamless and well-integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient, etc.
• Provides strategic consultation to brands and MCCO groups regarding key brand market events
• Creates appropriate marketing budgets by working with peers, manager and/or other internal partners
• Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives. Regularly reviews forecasting and other business analyses and uses to make appropriate further recommendations to increase market access, address currently unmet needs, and generally help to improve the overall market strength for Genentech in assigned managed care segments
• Directly manages the implementation of all assigned managed care marketing plans and tactics to ensure timely and quality execution that will meet or exceed assigned targets, goals and objectives
• Works with others to identify, recommend, create and help implement new account management tools/resources that will enable the field to represent Genentech in accordance with the defined strategy and position
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

This role provides technical and business leadership to IT and our internal business partners; its primary focus is developing and improving business processes. The individual acts as a business relationship manager responsible for the collection, analysis, review, documentation, and communication of business requirements and needs. The individual also acts as a liaison between IT and business units or vendors, establishing relationships with employees and key stakeholders. The individual is responsible for designing solutions with architecture, engineering, and various IT entities. The role also assists with the development of metrics, both within the technology and business organizations. The solutions must be developed at the best possible cost and aligned with customer and business needs. The individual oversees the development and implementation of corporate standards, technology architecture, technology evaluation, and life cycle. To be successful, the individual must possess a combination of business, technical, and leadership skills. This requires an understanding of customers’ business needs, processes, and functions.  They also need a solid knowledge of IT infrastructure, architecture, applications development, and support. In addition they must possess excellent communication skills and the ability to influence others. They must be able to quickly assess the impact of technical issues on the business and make decisions appropriately

• Lead and/or participate in tech transfers of purification processes across Roche/Genentech’s drug substance manufacturing facilities and to external contract manufacturing facilities.  Requires close collaboration with cross-functional team to implement, validate, and license Drug Substance processes at receiving sites.
• Responsible for providing on-going technical support for Drug Substance production at contract and partner sites. Includes monitoring process performance, resolving manufacturing deviations, participating in quality investigations, and providing technical approval of document and automation recipe changes to support continuous process improvement.
• Lead and/or participate in global initiatives and cross-functional teams in the areas of downstream processing.
• Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process design and operations to ensure consistency and compliance across the biologics manufacturing network.
• Represent MSAT Network on corporate initiatives led by partner groups such as Quality, Regulatory, Manufacturing Operations, Pharma Technical Development, etc.
• Provide technical leadership for topics including support for proposed manufacturing process changes, process validation, discrepancy and investigation evaluations, change control, and regulatory submissions. Some lab work may be required in order to resolve investigations and/or demonstrate proof-of-concept for proposed process changes.
• Responsible for authoring and reviewing technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing processes at new manufacturing sites.
• Travel within the Roche network and to contract manufacturing sites will be required.

Main Purpose of the Position

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug substance (DS) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche and the CMO as the Roche’s single point of contact for the contract manufacturing relationship at the Joint Management Committee and Joint Steering Committee levels.

* Build and lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

* Manage the performance and development of direct reports as required to achieve organizational and department goals and a productive work environment.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Build and lead the Roche cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Build and lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche’s DS products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including serving as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche’s DS manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management.  Build and lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, coordinating technical review of process data and proposed facility, equipment, system, or process changes with Roche Subject Matter Experts (SME's).

* Facilitate issue resolution and problem solving within CMO site, with Roche functional departments supporting Contract Manufacturing, and through the agreed project governance structure as appropriate.

* Coordinate cross-enterprise forecasting, capacity planning, scheduling, and inventory management processes for critical raw materials and DS.  

o...

Sr. Finance Manager – Pharma Finance Development (PFD), South San Francisco

Description:

The Pharma Finance Development group has ~ 45 people in multiple locations around the globe.  It is a cross-functional, cross-cultural group that supports the Roche Product Development organization.  This role is based in South San Francisco and reports directly to the Director of SSF Pharma Finance Development. 

The Senior Finance Manager is responsible for providing financial management and decision support to the Product Development organization. 

Major Responsibilities:
•   Provide local financial controlling support to several functions within Product Development (Biometrics, Portfolio Management, Global Medical Affairs, Quality)
•   Provide global controlling support in collaboration with global functional controller for Biometrics
•   Act as internal consultant by providing financial consultation and guidance to business partners as needed;  support business in understanding state of finances and actions required to achieve business objectives
•   Provide support for all budgets & forecasts for respective local and global functions supported throughout the year
•   Prepare and present monthly financial results to functional leadership
•   Participate and drive key strategic projects for PFD in support of Product Development
      o Provide strategic financial analytical support that both measures and drives efficiencies within the Development organization and improves decision making
      o Present analysis to PFDLT and the PDLT sub-functions
•   Collaborate with Global Controllers, Life Cycle Controllers and Global Development Heads on cross-functional projects and to ensure Product Developments meets its business objectives

The Position

• Perform final review, cumulative review and disposition of Genentech manufactured cell banks and clinical drug substance, drug product and final drug product.
• Review and approve procedures, tickets and other clinical QA controlled documentation. 
• Provide clinical trial support such as COA/COC/COT requests.
• Provide support and oversight of manufacturing activities on the floor.
• Manage batch disposition activities to ensure that products are dispositioned in accordance with cGMPs, Regulatory, and Genentech Policies and Procedures and adherence to schedule.  
• Set personal performance goals and collaborate with management to establish organizational objectives.  
• Manage competing priorities to meet department and organizational targets and timelines.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Apply advanced theory, technical principles, and judgment to address a broad range of difficult problems.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• Be accountable for behaviors as described in Genentech's Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support Quality oversight activities.
• Interface with appropriate departments to ensure that batch disposition items are complete and timely notification to Management of all known delays and significant Quality issues is provided
• Interact with interdepartmental contacts on discrepancy assessment, resolution, and Quality approval
• Support and present in Internal and Regulatory Inspections.
• Participate in the resolution of Quality issues by fostering effective interdepartmental and cross-functional relationships.
• Participate or lead different internal or cross functional projects relevant to QA lot disposition
• Train new personnel and internal customers on relevant business processes.
• Ability to revise or create work instructions, SOPs and business process instructions.

Job Purpose:

The PDQA GCP TA Strategy Lead is responsible for the development and implementation of a GCP risk based strategy to deliver an audit program and quality oversight model for studies/products within a therapeutic area.  This role provides oversight to the PDQA program contacts to ensure consistent application of risk based strategy for each program within a TA, and provide actionable data to Therapeutic Area Senior PD management based on analysis of data (audit/inspection/risk) and identification of trends.  This role is to influence TAs in the area of risk and quality management so they can proactively identify and address issues.

Primary Responsibilities and Accountabilities:

• Design and implement a global GCP risk-based Strategy for audit and risk assessment activities for each program in a TA
• Develops and performs risk assessment strategy on each program in TA 
• Supports Program Contacts in risk assessment for each study in program and helps define PDQA priority studies list 
• Develop and maintain risk assessment tools
• Monitors risk data and recommends risk mitigation strategies to TA
• Oversee completion of TA and protocol specific Quality plans
• Input program specific information into risk assessments of internal processes and service providers
• Provide back-up support to all Program Contacts for a specific TA
• Assess and adjust the audit strategy for CTC audits (internal and compliance audits)
• Functions as an audit report reviewer for outsourced CTC Compliance audits
• Analyze data/metrics from audits, inspections and risk management activities for compliance trends and risks for all programs within a specific TA 
• Develop and deliver summary reports (audit/inspection/risk metrics and trends) to TA Leadership
• Provide compliance advice to the TA/product teams and PDQA staff
• May lead or participate in GCP audits for TA 
• Support inspection readiness and inspection management activities for products within a TA
• Support regulatory authority GCP inspections for products in Therapeutic Area

• Provides leadership and direction to PDQ/PDQA and our customers/stakeholders on GCP related activities/issues 
• Establish strong partnership/relationship with TA Senior PD Management
• Review and provide feedback on study risk mitigation plans/CAPAs 
• Escalate significant compliance issues to PDQA Management
• Support PDQ Partner Services in the implementation and oversight of QMS for PDG 
• Provide responses to GCP questions received from Compliance Help Desk for TA

• Contribute to the development and execution of PDQA goals and initiatives
• Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned
• Assists and/or contributes to the development and/or revision of PDQA SOPs, guidelines and tools

• Maintains highest level of awareness, expertise in international GCP regulations and internal policies and SOPs

Responsible for the administration and operation of the site’s programmable logic controllers (PLC) and provides instrumentation and control engineering expertise to the Engineering Group. Focus on providing operational support for existing facilities with respect to the instrumentation and control systems for process, utility and building systems. Provides operational support and interfaces with the Siemens Building Management and Emerson Delta V systems as needed. 

Job Responsibilities

Essential
Serve as the site subject matter expert for the various PLC systems
Act as the PLC system super user and ensure system equipment and software are maintained in an operational state
Train personnel to interface with PLC systems on equipment and add or delete users based on training status.
Generate alarm reports, identify trends and review data with Quality.
Perform instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement.
Review and approve design drawings, and Process & Instrumentation Diagrams which include all line sizing, instrumentation and control philosophies,
Review design specification testing and perform field inspection services.
Interact with vendors.
Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.
Play a lead role in the start-up and troubleshooting of process equipment and critical process utility systems.
Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and systems located in existing facilities. Examples include functional specifications and detail design specification.
Provide input into the validation of process equipment and associated utilities.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities
Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.

PTR Regional Hub Sr. Regulatory Associate (E3) /

PTR Regional Hub Regulatory Manager (E4)1

Department: Pharma Technical Regulatory (PTR)

Job Family / Category: PTR Regional Hubs

Purpose

This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

Responsibilities:

* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network.

* In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.

* Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* The candidate may be required to travel to other Roche sites on a periodic basis.