Director of CMC Strategy
5 days ago
About the Role: We are looking for an experienced professional to join our team as a Director of Policy and Regulatory Affairs. This role will be responsible for leading key strategic CMC regulatory activities for investigational and early commercial biological products.
Key Responsibilities:
- Lead key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceuticals
- Provide strategic direction and guidance on both global project and key strategic business initiatives
- Develop and implement effective CMC regulatory strategies to support major inspections or quality incidents
Requirements:
- Master's degree in a relevant field (e.g., pharmaceutical sciences, regulatory affairs)
- Minimum 8 years of experience in CMC regulatory affairs, preferably in a biopharmaceutical industry
- Proven track record of leading complex projects and teams
What We Offer:
- A competitive salary range of $150,000 - $200,000 per year
- A comprehensive benefits package, including medical, dental, and vision insurance
- A generous 401(k) matching program
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