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
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