REGULATORY CMC MANAGER

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 complianceQualifications:Education:Bachelor’s, Master’s, or Ph.D. in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related discipline.Experience:8+ 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.).Key Competencies: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.