Regulatory CMC manager

Direct message the job poster from Discover International

Director / Europe / Perm / Retained Search

Key Responsibilities :

Regulatory CMC Strategy & Life Cycle Management :

• Lead and support the development and execution of global regulatory CMC strategies for large-molecule products, with a focus on analytical life cycle management.
• Manage post-approval regulatory activities, including CMC variations, supplements, and amendments related to analytical methods.
• Maintain oversight of analytical method changes, ensuring compliance with regulatory guidelines and standards.

Analytical Method Development & Validation :

• Collaborate with analytical and quality control teams to oversee the development, validation, and transfer of analytical methods for large molecules.
• Ensure compliance of analytical methods with global regulatory requirements, and manage any related submissions or responses to health authorities.

Regulatory Submissions & Documentation :

• Prepare and review high-quality CMC sections for regulatory submissions (IND / IMPD, BLA / NDA, MAA, variations / supplements).
• Ensure CMC documentation (module 3 and regional-specific requirements) meets current regulatory guidelines and scientific standards.
• Address questions and deficiencies raised by global health authorities regarding CMC and analytical method sections.

Cross-functional Collaboration :

• Act as the key liaison between regulatory affairs and analytical development, quality control, manufacturing, and supply chain teams.
• Provide regulatory guidance and risk assessments for analytical-related changes throughout the product life cycle.
• Support internal teams on regulatory intelligence and changes in CMC regulatory guidance, with a focus on analytical expectations.

Health Authority Interactions :

• Lead and participate in meetings and communications with global regulatory authorities, addressing CMC / analytical-related questions and providing technical expertise.
• Maintain strong knowledge of evolving regulatory requirements, guidance, and industry standards for large molecules and analytical methods.

Compliance & Continuous Improvement :

• Ensure adherence to global regulatory guidelines (FDA, EMA, ICH, etc.) and internal quality management systems.
• Proactively identify regulatory risks related to analytical methods and propose mitigation strategies.
• Support the implementation of process improvements within the regulatory CMC function to enhance efficiency and regulatory compliance.

Qualifications : Education :

• Bachelor’s, Master’s, or Ph.D. in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related discipline.

Experience :

• 5+ years of experience in Regulatory CMC with a focus on large molecule / biologics, including life cycle management.
• Strong experience in analytical method development, validation, and regulatory submission.
• Proven experience with global regulatory submissions (IND / IMPD, BLA / NDA, MAA) for large molecules.
• Experience interacting with health authorities, including FDA, EMA, and other global agencies.

Technical Skills :

• In-depth knowledge of CMC regulatory requirements for large-molecule biologics.
• Strong expertise in analytical methods for biologics, including method development, validation, and troubleshooting.
• Familiarity with global regulatory requirements, including ICH guidelines and major regional regulations (FDA, EMA, etc.).
• Excellent project management skills with the ability to lead and manage multiple regulatory projects in a fast-paced environment.
• Strong communication and interpersonal skills for cross-functional collaboration and health authority interactions.
• Analytical thinking, problem-solving abilities, and attention to detail.
• Ability to work independently and lead cross-functional teams on CMC-related matters.