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Regulatory Affairs Director
1 month ago
We are seeking an experienced Associate Director of Regulatory Affairs to join our team at Revolution Medicines, a clinical-stage precision oncology company dedicated to developing novel targeted therapies for RAS-addicted cancers.
The OpportunityAs a key member of our Regulatory Affairs team, you will provide strategic leadership and guidance on regulatory matters related to our clinical development programs in oncology. Your expertise will be instrumental in ensuring compliance with applicable regulations and facilitating successful regulatory outcomes.
Key Responsibilities- Develop and implement regulatory strategies for assigned programs, ensuring alignment with company goals and objectives.
- Plan, prepare, and coordinate regulatory submissions, including NDA filings, to ensure high quality and timely delivery.
- Collaborate with cross-functional teams, including Clinical Research, Clinical Operations, and Medical Writing, to ensure effective communication and alignment.
- Maintain a working knowledge of the dynamic regulatory landscape in oncology and translate this into actionable steps.
- Manage direct reports and provide mentorship to junior professionals.
To be successful in this role, you will need:
- A degree in biological or life sciences, pharmacy, medicine, or a related field.
- At least 7 years of experience in the pharmaceutical/biotech industry or relevant work experience, with a minimum of 4 years in Regulatory Affairs.
- Direct experience with immuno-oncology drug development and checkpoint inhibitors is highly preferred.
- Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols is highly preferred.
- Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy.
As a member of our team, you will enjoy a competitive salary range of $160,000 - $200,000, depending on location, as well as robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
