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regulatory affairs fda cmc cell therapy ind/cta📋 Description
- Be accountable for regulatory CMC activities for Retro’s programs.
- Develop the regulatory CMC strategy and lead global plans.
- Lead the preparation of the CMC dossier for INDs/CTAs and amendments.
- Act as Retro’s regulatory liaison with health authorities for CMC.
- Lead health-authority meetings for CMC topics.
- Identify regulatory CMC risks and mitigation strategies.
🎯 Requirements
- Bachelor’s degree in life sciences (advanced degree preferred).
- 7+ years of hands-on regulatory CMC experience.
- Experience leading CMC regulatory strategy for cell therapies.
- Experience in early phase development (IND/CTA through Phase 1/2).
- Lead cross-functional workstreams and deliver high-quality outputs on time.
- Strong interest in longevity and aging biology.
🎁 Benefits
- Medical, dental, and vision insurance for you and your family
- 401(k) plan with 4% matching
- Unlimited time off and 10 company holidays per year
- Paid parental leave
- Annual learning & development stipend
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