Therapeutic Area Head, Regulatory Affairs
About The Position
The Opportunity: Provide management and leadership of one or more therapeutic areas for late-stage oncology programs. Oversee the development of global regulatory therapeutic area and product strategies to drive product development, global registration, , and effective regulatory agency interactions. Provide regulatory expertise and guidance to therapeutic area commercialization teams and other governance bodies. Foster the career development of staff within the therapeutic area and contribute to departmental leadership activities. Ensure alignment and consistency across programs within a therapeutic area based on regulatory intel, research, and competitive landscape. Primary Responsibilities: Direct the development of global regulatory strategy from registrational studies to marketing application across one or more therapeutic areas. Lead and mentor GRLs/Study Leads in the development of global regulatory strategies, in partnership with regional regulatory leads, including precedence, risk management and contingency planning. Partner with regional regulatory leads to incorporate regional regulatory, scientific, clinical, and market insights into integrated disease area and product strategies. Communicate to management aligned global regulatory strategy and plans for a therapeutic area to support portfolio and life cycle management. Conduct management review and approval of key documents for regulatory submissions and governance communications. Contribute to the target product profile and evaluation of probability of regulatory success. Monitor, assess and communicate to staff impact of relevant global regulations, guidance, and current regulatory environment. Advise on global health authority interactions and participate on core regulatory and cross-functional teams to ensure effective agency interactions. Provide managerial leadership & direction to staff within the therapeutic area, allowing appropriate prioritization of resources to achieve corporate goals. Provide coaching, mentoring, and development of staff, ensuring staff are compliant with Revolution Medicine’s corporate and departmental policies and procedures.
Requirements
- Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
- Prior marketing application filing experience. Demonstrated success in obtaining health authority approvals.
- Demonstrated ability in leading teams, establishing organizational direction, and championing continuous improvements.
- Direct experience with global oncology drug development.
- Experienced in representing Regulatory on cross functional teams and presenting to senior management. Proven ability to anticipate challenges and future risks and mitigate against potential strategic issues.
- Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
Nice To Haves
- An advanced degree is desirable.
- Experience with combination studies, multiple expansion cohort, global registrational studies, basket or umbrella and master protocols highly preferred.
Responsibilities
- Direct the development of global regulatory strategy from registrational studies to marketing application across one or more therapeutic areas.
- Lead and mentor GRLs/Study Leads in the development of global regulatory strategies, in partnership with regional regulatory leads, including precedence, risk management and contingency planning.
- Partner with regional regulatory leads to incorporate regional regulatory, scientific, clinical, and market insights into integrated disease area and product strategies.
- Communicate to management aligned global regulatory strategy and plans for a therapeutic area to support portfolio and life cycle management.
- Conduct management review and approval of key documents for regulatory submissions and governance communications.
- Contribute to the target product profile and evaluation of probability of regulatory success.
- Monitor, assess and communicate to staff impact of relevant global regulations, guidance, and current regulatory environment.
- Advise on global health authority interactions and participate on core regulatory and cross-functional teams to ensure effective agency interactions.
- Provide managerial leadership & direction to staff within the therapeutic area, allowing appropriate prioritization of resources to achieve corporate goals.
- Provide coaching, mentoring, and development of staff, ensuring staff are compliant with Revolution Medicine’s corporate and departmental policies and procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
