Related skills
regulatory affairs veeva cmc cta ind📋 Description
- Provide strategic Regulatory CMC leadership across biologics for late-stage development.
- Lead global CMC regulatory submissions (INDs, CTAs, BLAs, MAAs).
- Serve as primary representative for CMC Health Authority interactions.
- Support global Phase 3 programs by coordinating regional submissions.
- Partner with Technical Operations, Quality, and Supply Chain to align regulatory needs.
- Stay current with evolving global CMC regs; translate into internal strategies.
🎯 Requirements
- 10+ years in Regulatory Affairs in biotech/pharma with CMC focus.
- Experience supporting Phase 3 global programs and IND/CTA/BLA/MAA submissions.
- Led CMC Health Authority meetings, briefs, and regulatory negotiations.
- Deep knowledge of biologics manufacturing, analytics, and quality systems.
- Bachelor's degree required; advanced degree preferred.
- Familiar with eCTD standards and regulatory data systems (Veeva).
🎁 Benefits
- Annual bonus eligibility.
- Equity compensation.
- Competitive benefits package.
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