Cmc Regulatory Affairs Manager Milano

Cmc Regulatory Affairs Manager
Milano
Lombardia, Milano

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.