The Global Regulatory Director PHC is a global role and is providing regulatory leadership for an assigned PHC Project, in order to support and drive all of its regulatory aspects
The individual will be an integral member of the PDR Digital Team, and will therefore also facilitate internal position building, cross-functional alignment and strategy development, as well as providing policy support on position papers, HA interactions with the intent to embed the strategies, skills, and knowledge within and across PDR.
The individual is expected to lead global complex PHC projects and represent PDR to cross-functional teams and groups.
The individual is responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners.
The individual serves as the principal interface with primary reviewers from health authorities / Notified Bodies and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.
The individual must be capable of working in a matrixed and de-centralized environment across many key internal stakeholder groups as well as across Roche Pharma.
The individual will need to have skills that result in effective influence in the absence of a reporting line.
CONTEXT AND RESPONSIBILITIES:
1. Intact & Cross-Functional Teams
Is an active contributor to PHC Strategies for Roche Pharma in general
Participates in site, regional and/or global PDR departmental meetings
2. Global Regulatory Director - Personalized Healthcare
Establish regulatory strategies related to PHC
Stay abreast of global developments and trends in healthcare, technology / diagnostics and competition relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned areas and projects.
Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs, device and biologics.
Briefs teams and management, as appropriate
Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
Provides regulatory expertise and leadership to site, regional or global cross-functional teams and other groups
Serves as the primary PDR representative on one or more regional or global projects at any one point in time; typically, complex projects
Analyzes data, the regulatory environment and business objectives to recommend priorities
Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.
Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche
Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development
Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
Works with others to ensure timely and appropriate cross-functional alignment and appointment to regulatory team for each assigned project
Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management
Serves as the site, regional or global principal interface with primary reviewers from regulatory authorities/notified bodies or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities/notified bodies and directs regulatory interactions for internal site, regional and/or global teams
Provides internal teams with direction on regulatory authority interactions
Manages ongoing Regulatory Team meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.
Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made
Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary
Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and meet regulatory and other company guidelines
Develops regulatory risk management and contingency plans. Communicates plans to management, as appropriate
Works with other functions and functional management to ensure the relevant regulatory team has appropriate budget and resources to meet objectives. Manages or co-manages relevant project budgets to ensure compliance with agreed parameters and provides routine and ad hoc budget reporting and other updates
As relevant, provides day-to-day guidance and direction to less experienced Regulatory staff and their work supporting the same projects or other assignments
Provides and receives direct and objective performance feedback on/from cross-functional team members
Is pivotal at embedding PHC 2.0 knowledge within PDR
Communication of global strategy throughout national Roche affiliate in alignment with other key stakeholders
Is a global role, can be based at any site and international travel is required
As assigned, participates in recruitment activities and on-boarding new staff members
As assigned, trains, coaches and mentors new or less experienced staff members
Participates in and/or otherwise supports development and implementation of new or updated PDR systems, processes, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant tools
Completes other routine and ad hoc analysis and reporting.
Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
Leads other special projects, as and when assigned, or otherwise requested
Participates in routine and ad hoc departmental meetings and other business reviews or meetings to remain, at all times, fully abreast and apprised of evolving internal and external needs and requirements. Expected to share best practices within the department and cross-functionally, identify and communicate opportunities for departmental enhancements and efficiencies
Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines
Candidates for this position should have the following experience level, and be able to demonstrate the following abilities to be considered as a suitable applicant. All points listed below are considered minimum requirements.
Average of 7 or more years’ relevant experience in regulatory affairs or related functions in drug/biologics development/device/manufacturing
Broad understanding of international regulations, processes and issues in drug/biologics/device development. Includes in-depth knowledge of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, Medical Device Regulation, NICE and other relevant guidelines
Familiar with competitive activity in the field
Experience participating in global product development teams
Experience as a regulatory contributor for global original IND/NDA/MAA filings in the US or Europe is strongly preferred
Ability to work with HAs / NBs, prior experience in medical device as well as clinical development are strong plus.
Previous people management (matrix management) experience
International (2 or more markets) regulatory experience is a strong plus
Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
Fluent English and other language skills as needed
Is regarded as a subject matter expert, is respected by others, and can effectively contribute to long-range product development and consistently leads cross-functional teams to successful results
Strong business acumen: has in-depth knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process. Can effectively contribute to development of disease strategies and plans
Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
Outstanding written communication skills
Strong business presentation skills: effective at summarizing and presenting the key considerations and decision-points
Confident and competent when interacting with varying levels of internal/external management: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy
Strong financial acumen: proven abilities for planning, development and oversight of project budgets and other resources
Strong cross-functional teaming skills: has consistently excelled in cross-functional teams and regularly demonstrated him/herself as a leader among peers
Aptitude or proven ability to guide the work of others (can lead and motivate others, as well as prioritize and oversee their work through to successful outcomes)
Ability to travel (<30%)
Is responsible for acting in line with legal, regulatory and company standards and codes of practice (such as Roche Code of Conduct and any other Roche directives and guidelines)
Completes all required training modules as a priority. In case of line management, is responsible for the team members to act similarly
Works with All PD Functions / PDR / PTR / Roche Diagnostics to ensure alignment with the broader Roche PHC strategy and processes including compliance requirements and alignment with Roche SOPs
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