Mantell Associates
Mantell Associates is partnered with a Cell & Gene Therapy organisation, who is seeking a CMC Regulatory Affairs Manager to join their growing team.
CMC Regulatory Affairs Manager – Responsibilities:
- Help the team implement and manage CMC regulatory strategies for gene therapy projects, ensuring everything aligns with regulatory requirements
- Contribute to the regulatory strategy for clinical trials and commercial products by preparing CMC sections of regulatory dossiers, performing gap analyses, and helping address any missing information
- Provide support during Regulatory Authorities inspections by ensuring that all necessary CMC regulatory information for investigational and commercial products is organized and compliant
- Assist in preparing and managing CMC aspects of regulatory documents for assigned projects, including managing CMC-related requests for Orphan Drug Designation (ODD), Scientific Advice, and Pediatric Investigation Plans (PIP)
- Contribute to initial regulatory submissions for clinical trials and commercial products, and support the regulatory process throughout the product lifecycle, including submissions for changes to marketing authorizations (MAA/BLA) and investigational product dossiers (IMPD/IND)
- Stay on top of regulatory updates and contribute to the team’s strategy to ensure they always meet the latest standards, especially for orphan drugs, advanced therapies (ATMP), GMP, and compliance
- Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.)
- Work in collaboration with the Quality Assurance and CMC teams to evaluate any events affecting product quality, such as deviations or out-of-specification results, and help managing change controls performing the regulatory impact assessment
CMC Regulatory Affairs Manager – Requirements:
- 5-7 years of experience in CMC Regulatory Affairs
- Experience in CMC/GMP within the Cell & Gene field will be also considered
- Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemistry, Biology, Pharmaceutical Sciences, or a related life sciences field
- Previous experience in Regulatory Affairs, GMP, or CMC in the pharmaceutical or biotech industry
- Previous experience with Cell & Gene Therapies
- Excellent English oral and written communication skills
- Ability to work autonomously and prioritize workflow
- Demonstrated analytical, problem resolution and communication skills
- Strong communication and organizational skills to manage regulatory documents and collaborate with global regulatory bodies
- Attention to detail, with the ability to manage multiple tasks in a regulated environment
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.