Cmc Regulatory Affairs Manager

3 settimane fa

Milano, Lombardia, Italia Rf Roberto Fantoccoli 1975 Srl A tempo pieno

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 provide 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 manage 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.
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