CMC Regulatory Director at The Judge Group Inc. in New York, New York

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.

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Contact: jgood@judge.com


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