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Senior Director, Regulatory Affairs
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Full-time
- Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations.
- Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets.
- Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success.
- The Senior Director, Regulatory Affairs will lead and formulate the regulatory affairs strategy for pharmaceutical products.
- Analyze FDA regulatory requirements for all pharmaceutical dosage forms, applying Analytical method development and validation, USP/NF, 21 CFRs FDA guidelines;
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