Job Description:
Location: REMOTE
Salary: $150,000.00 USD Annually - $175,000.00 USD Annually
Description:
Our client is currently seeking a CMC Regulatory Director. This is a permanent, direct hire position offering a remote schedule, with as needed travel.
Responsibilities:
- Develop and implement CMC regulatory strategies for drug development and post-approval changes.
- Lead CMC submissions (IND, NDA, BLA, MAA) and agency interactions.
- Guide product creation and market entry, ensuring regulatory compliance.
- Author and approve CMC sections for submissions, amendments, and variations.
- Direct cross-functional submission teams for regulatory documents within timelines.
Qualifications:
- Advanced degree (Ph.D., MS) in chemistry, pharmaceutical sciences, or related field.
- 8+ years in Regulatory Affairs with a focus on CMC in biotech or pharmaceuticals.
- Strong knowledge of FDA, EMA, ICH guidelines.
- Proven experience with CMC regulatory submissions and post-approval activities.
- Excellent project management and communication skills.
Contact: jgood@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
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