Director Regulatory CMC

Regulatory Connect; United States; Remote; USD 180,000 - 250,000; Full time

Job summary

Regulatory Connect in the United States is seeking an experienced Associate Director / Director, CMC Regulatory Affairs to lead CMC regulatory strategy for US and global programs. You will own submission content and interact with health authorities, coordinating cross-functional teams to maintain submission timelines.

The role requires a strong track record in CMC, FDA/EMA experience, and the ability to work independently while driving complex regulatory activities across development and

Qualifications

• 10+ years of pharmaceutical or biopharmaceutical experience, including at least 8 years in CMC Regulatory Affairs.
• Strong experience developing CMC content for development and post-approval submissions.
• In‑depth knowledge of ICH guidance, eCTD Module 3, IMPD, and global CMC requirements.
• Direct experience supporting FDA and/or EMA interactions on CMC matters.
• Scientific bachelor’s degree; an advanced degree and RAC certification are preferred.
• Experience with biologics, biosimilars, or endocrine products is an advantage.
• Excellent written and verbal communication skills, strong attention to detail, and the ability to manage multiple priorities independently.

Responsibilities

• Develop and execute CMC regulatory strategies for US, EU, and other global markets.
• Review and provide regulatory oversight for CMC submission content, including IND/CTA, NDA/BLA/MAA, and post-approval submissions.
• Ensure CMC sections meet applicable FDA, EMA, ICH, eCTD Module 3, and IMPD requirements.
• Support health authority interactions, meeting preparation, agency questions, and deficiency responses.
• Partner with formulation, analytical, manufacturing, quality, and regulatory colleagues to identify risks and keep submissions on track.
• Support post-approval activities, including supplements, variations, and annual reports.
• Help establish CMC regulatory processes and best practices.

Skills

Regulatory leadership

CMC Regulatory Affairs

Regulatory submissions

FDA/EMA interactions

Education

Bachelor's degree in science

Job description

Associate Director / Director, CMC Regulatory Affairs

Remote- United States | Full-time

We're partnering with a biopharmaceutical company who are looking to recruit an experienced CMC Regulatory Affairs leader for a pivotal role supporting its US and global development programs.

This is an opportunity to take ownership of CMC regulatory strategy and submissions, working closely with cross-functional and international teams. The successful candidate will bring strong technical judgement, clear communication skills, and the ability to work independently while coordinating complex regulatory activities.

The role

• Develop and execute CMC regulatory strategies for US, EU, and other global markets.
• Review and provide regulatory oversight for CMC submission content, including IND/CTA, NDA/BLA/MAA, and post-approval submissions.
• Ensure CMC sections meet applicable FDA, EMA, ICH, eCTD Module 3, and IMPD requirements.
• Support health authority interactions, meeting preparation, agency questions, and deficiency responses.
• Partner with formulation, analytical, manufacturing, quality, and regulatory colleagues to identify risks and keep submissions on track.
• Support post-approval activities, including supplements, variations, and annual reports.
• Help establish CMC regulatory processes and best practices.

What they're looking for

• 10+ years of pharmaceutical or biopharmaceutical experience, including at least 8 years in CMC Regulatory Affairs.
• Strong experience developing CMC content for development and post-approval submissions.
• In-depth knowledge of ICH guidance, eCTD Module 3, IMPD, and global CMC requirements.
• Direct experience supporting FDA and/or EMA interactions on CMC matters.
• A scientific bachelor’s degree; an advanced degree and RAC certification are preferred.
• Experience with biologics, biosimilars, or endocrine products is an advantage.
• Excellent written and verbal communication skills, strong attention to detail, and the ability to manage multiple priorities independently.