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Director, Regulatory Affairs, CMC - Combination Products
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Full-time
- Works effectively across a complex matrix environment with GRLs, CMC RA, Program Leadership, CMC functions, etc.
- Relationship management and constructive partnering with global Health Authorities (e.g., FDA, EMA, PMDA, NMPA, Competent Authorities, etc.)
- Regulatory CMC experience in medical device and combination product research, development and/or manufacturing
- Regulatory CMC experience in authoring and review of (IND, CTA, BLA, MAA) with a drug-device combination product
- Membership/panelist/presenter within a combination-products related professional society/forum
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