CMC Regulatory Director Position Available In Fulton, Georgia

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. By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively “Judge”) to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge’s Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.

Contact:

jgood@judge.com This job and many more are available through The Judge Group. Find us on the web at www.judge.com