Director, Regulatory Affairs
Enigma Search
Director, Regulatory Affairs
South San Francisco, California, United States
Are you a seasoned Regulatory Affairs professional ready to make a significant impact on human health? We are seeking a strategic and driven Director of Regulatory Affairs to join a pioneering research and development company focused on extending healthy lifespan.
This is an exceptional opportunity to play a pivotal role in developing and implementing innovative regulatory strategies for groundbreaking programs. You will collaborate with cross-functional teams and external partners, driving regulatory success from IND-enabling studies through clinical proof-of-concept and beyond.
Your Impact:
- Develop and execute global regulatory strategies for assigned programs, including first-in-class therapies and programs with external partnerships.
- Lead interactions with global health authorities, preparing briefing packages and ensuring clear communication.
- Collaborate with executive leadership to define regulatory strategies aligned with the company's mission.
- Oversee the preparation and submission of regulatory applications, ensuring accuracy and timeliness.
- Develop effective CMC regulatory strategies in collaboration with Technical Operations.
- Provide strategic regulatory input to development teams, protocols, reports, and other critical documents.
- Stay ahead of global regulatory changes, communicating updates and developing proactive strategies.
- Collaborate with cross-functional teams and external consultants.
What You Bring:
- Masters degree in a life science discipline (PhD preferred).
- Minimum of 10 years of regulatory affairs experience in industry, academia, or clinical research, with experience in rare disease development and/or novel endpoints.
- Proven track record of developing regulatory submissions, including experience with major approvals (NDA, BLA, MAA, etc.).
- Strong knowledge of global regulations (FDA, EMA, etc.).
- Experience with mechanisms to expedite agency interactions.
- Advanced skills in creating and assessing regulatory proposals and leading health authority interactions.
- Excellent communication and influencing skills.
- Self-motivated, strategic thinker with strong problem-solving skills.
- Exceptional organizational and prioritization skills.
- Ability to thrive in a fast-paced, collaborative, start-up environment.
- Must be willing to work onsite at least four days per week.
Vacancy posted 3 days ago
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