Enveda exists to give hope to millions of people around the world by accelerating the discovery of better medicines. Backed by Lux.
About the role
As a Global Regulatory Strategy Director at Enveda, you'll lead the development and execution of innovative regulatory strategies for our pipeline of first-in-class small-molecule medicines. You'll partner with global project teams as the regulatory subject matter expert and lead Enveda's interactions with health authorities worldwide. In your first year, you'll shape our global registrational strategies and lead the submissions that support them. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor's degree in a scientific discipline, an advanced degree (MS, PharmD, or PhD) is preferred
- At least 12 years of Regulatory Affairs experience in pharma or biotech, experience across all phases of development is highly preferred
- Strong negotiation skills with health authorities (e.g., FDA, EMA, Health Canada), plus submission experience from IND/CTx through NDA or marketing applications
- Experience developing and executing regulatory strategies for oral small-molecule programs, and experience in obesity or dermatology, both strongly preferred
- Excellent oral, written, and presentation skills, including experience presenting to leadership teams
- Demonstrated organizational awareness, including experience representing Regulatory Affairs cross-functionally and on global teams
More about this role
As a Global Regulatory Strategy Director at Enveda, you'll lead the development and execution of innovative regulatory strategies for our pipeline of first-in-class small-molecule medicines. You'll partner with global project teams as the regulatory subject matter expert and lead Enveda's interactions with health authorities worldwide. In your first year, you'll shape our global registrational strategies and lead the submissions that support them. This is a high impact opportunity where you'll influence our global regulatory strategy and small-molecule clinical pipeline while collaborating with some of the brightest minds in the industry.
- Provide regulatory leadership for Enveda's assets through Phase 2 and beyond, and lead the development of global registrational strategies
- With minimal supervision, develop innovative global regulatory strategies for Enveda's portfolio in clinical development and life-cycle management
- Lead the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, DMF, IMPD, and more), identifying gaps and developing risk mitigation strategies
- Represent Enveda with global health authorities and lead agency interactions to achieve...
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