Therapeutic Area Head, Regulatory Affairs

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.

Required Skills, Experience and Education:

• 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.

Preferred Skills:

• An advanced degree is desirable.

• Experience with combination studies, multiple expansion cohort, global registrational studies, basket or umbrella and master protocols highly preferred. 

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