Job Summary
Our client is currently seeking a CMC Regulatory Director. This is a permanent, direct hire position offering a remote schedule, with as needed travel.
The position requires strong product experience in Nasal spray and/or inhalation combination products.
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.
How to Apply
Interested candidates should submit their application online using the link below.
Apply Now
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