Senior Director & Therapeutic Area Head, Regulatory Affairs

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 Medicines’ 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.