Job Description

Job Description

About the Company

We are seeking an experienced Director, Regulatory CMC to provide strategic and operational leadership for Chemistry, Manufacturing, and Controls regulatory activities across a growing portfolio of development and commercial products. This role will serve as the CMC regulatory subject matter expert, ensuring compliance with global regulatory requirements while supporting efficient development, manufacturing, and lifecycle management. The Director will work closely with Technical Operations, Quality, Manufacturing, and Development teams and will represent CMC Regulatory in interactions with health authorities.

About the Role

This role will serve as the CMC regulatory subject matter expert, ensuring compliance with global regulatory requirements while supporting efficient development, manufacturing, and lifecycle management.

Responsibilities

• Lead the global CMC regulatory strategy for development and marketed products, ensuring alignment with business objectives and regulatory expectations.
• Provide oversight and authorship for CMC sections of regulatory submissions, including INDs/CTAs, BLAs/NDAs, supplements, variations, and annual reports.
• Act as the primary CMC regulatory representative in health authority interactions, including FDA meetings, scientific advice, and regulatory correspondence.
• Support CMC lifecycle management, including comparability assessments, post-approval changes, and regulatory impact evaluations.
• Partner cross-functionally with Technical Operations, Manufacturing, Quality, Analytical Development, and Supply Chain to ensure regulatory compliance and readiness.
• Ensure compliance with ICH guidelines, FDA, EMA, and other global regulatory requirements applicable to CMC activities.
• Contribute to internal governance forums, risk assessments, and regulatory decision-making processes.
• Build and maintain effective relationships with external partners, including CDMOs and regulatory consultants.
• Mentor and develop regulatory staff as appropriate, supporting a culture of regulatory excellence and accountability.

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PhD, PharmD) preferred.
• 10+ years of Regulatory Affairs experience, with significant focus on CMC in pharmaceutical or biotechnology environments.
• Demonstrated experience supporting IND, BLA, or NDA submissions, including CMC sections.
• Strong working knowledge of global CMC regulatory frameworks (FDA, EMA, ICH).
• Experience collaborating with manufacturing, quality, and technical operations organizations.
• Proven ability to operate effectively in an SME environment, balancing strategic oversight with hands-on execution.
• Excellent written and verbal communication skills, with the ability to clearly convey regulatory requirements and risk.

Required Skills

Strong working knowledge of global CMC regulatory frameworks (FDA, EMA, ICH).

Preferred Skills

Experience collaborating with manufacturing, quality, and technical operations organizations.

Pay range and compensation package

Competitive compensation and comprehensive benefits.

Equal Opportunity Statement

We are committed to diversity and inclusivity.

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