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Associate Regulatory Program Director

South San Francisco
California, United States of America


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The Position

The Associate Director of Regulatory Affairs will guide, develop, and execute the US regulatory strategies and plans. This position will interface with internal and external stakeholders including business partners and the US FDA. This role will involve assessment of regulatory aspects of new development opportunities for a marketed product. Strong leadership, collaboration skills and experience in sBLA submissions are highly desired.   

Intact & Cross-Functional Teams 

  • Participates in site, regional and/or global PDR Program Management departmental meetings 
  • Participates as a standing member in various teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams. Represents PDR in such capacities and coordinates cross-functional PDR contributions to product development projects and other related activities 
  • Leads the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution 
  • As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

Regulatory Program Management 

  • Stays abreast of internal and external developments, trends and other dynamics 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 therapeutic areas and projects. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs 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 and regional cross-functional teams and other groups 
  • Stays abreast of therapeutic area product development and other related business strategies and plans  
  • Serves as the primary PDR representative on one or more regional projects at any one point in time
  • 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 RAFT 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 and/or regional principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site and/or regional teams 
  • Provides internal teams with direction on regulatory authority interactions
  • Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources 
  • 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 Program Management 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 
  • As requested or otherwise appropriate, provides regulatory due diligence assessments in cooperation with other internal groups 

Other 

  • As assigned, trains, coaches and mentors new or less experienced Regulatory Program Management staff members 
  • Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Program Management-specific 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 
  • Participates in and/or otherwise 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

Qualifications & Experience:

  • Bachelors Degree with minimum 5 or more years’ of relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing
  • Broad understanding of international regulations, processes and issues in drug/biologics development, including GxP, GCP, ICH, and other relevant guidelines from FDA 
  • In-depth experience working with the principles and techniques of data analysis, interpretation and clinical relevance 
  • Comprehensive understanding of product and safety profiles
  • Experience with participating in global product development teams is preferred
  • Experience as a regulatory contributor for global original IND/NDA/MAA filings in the US or Europe is preferred
  • Strong written, interpersonal and communication skills   
  • Excellent project management 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

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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