CMC Regulatory Affairs Consultant

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We are seeking an experienced freelance CMC Regulatory Affairs Consultant to support the development, submission, and lifecycle management of regulatory CMC documentation for biologics, pharmaceuticals and/or advanced therapies. The consultant will provide strategic and operational guidance to ensure compliance with global regulatory requirements, while supporting product development and commercialization objectives.

Key Responsibilities

Develop, review, and submit high-quality CMC sections (Modules 2 & 3) of regulatory submissions (e.g., INDs, IMPDs, NDAs, BLAs, MAAs, amendments, supplements, variations).

Provide strategic CMC regulatory advice during development and lifecycle phases, including late-stage development and post-marketing.

Serve as a liaison between Regulatory Affairs, Manufacturing, Quality, and R&D to ensure alignment of regulatory strategy with product development.

Interpret and apply global regulatory guidance (e.g., FDA, EMA, ICH) to CMC activities.

Support interactions with regulatory agencies, including preparation for meetings (e.g., pre-IND, end-of-Phase 2, pre-BLA/MAA).

Monitor evolving regulatory CMC requirements and assess their impact on current and future submissions.

Review and assess changes to manufacturing processes and controls for regulatory impact and develop appropriate submission strategies.

Ensure timely and compliant execution of regulatory submissions and responses to health authority queries.

Qualifications

Bachelor\’s, Master\’s, or PhD in Chemistry, Pharmacy, Biology, or a related scientific discipline.

Significant experience in CMC regulatory affairs within the pharmaceutical or biotechnology industry.

In-depth knowledge of global regulatory requirements for drug substance and drug product development and manufacturing.

Demonstrated experience with successful regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs).

Strong understanding of quality systems, GMP, and ICH guidelines.

Excellent written and verbal communication skills.

Ability to work independently and manage multiple projects simultaneously in a fast-paced environment.

Preferred Qualifications

Prior consulting experience or experience working with regulatory authorities.

Experience with cell and gene therapies, biologics, or combination products.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

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