Regulatory Affairs Manager

With a growing regulatory team, an exciting opportunity has emerged for a Manager, Regulatory Affairs to contribute to the development of cutting-edge cell and gene therapy products. This role involves working within a global regulatory affairs team, overseeing the planning, preparation, review, and submission of regulatory applications to health authorities both in Europe and internationally. The successful candidate will play a vital role in advancing innovative Advanced Therapy Medicinal Products (ATMPs) within assigned therapeutic areas.

Key Responsibilities:

• Plan, coordinate, prepare, review, and submit regulatory applications and submissions (e.g., PIP, Orphan Designation, Variations) in collaboration with cross-functional teams.
• Support clinical studies by contributing to trial documentation development, document review, and submission planning in partnership with the Clinical Study Team and Regulatory Operations.
• Coordinate, prepare, review, and ensure the timely submission of responses to queries from Regulatory Agencies.
• Assist in the approval process and lifecycle management of regulatory applications and registrations for assigned products.
• Participate in planning, coordination, preparation, and execution of regulatory agency meetings.
• Contribute to the development and execution of regulatory strategies while proactively identifying and mitigating potential regulatory risks.
• Serve as a primary liaison with relevant Regulatory Agencies as needed.
• Ensure compliance with procedures related to Advanced Therapy Medicinal Products (ATMP/RMAT) and stay updated on evolving international regulatory requirements.
• Monitor industry developments and provide regulatory insights to development project teams and clinical operations.
• Stay informed on regulatory intelligence related to cell and gene therapy.
• Collaborate with cross-functional teams (e.g., Research, Pre-Clinical, Manufacturing, Clinical Operations) and external partners to ensure high-quality, timely regulatory submissions.
• Ensure regulatory activities align with company policies, standards, and ethical guidelines.
• Perform additional duties as required in alignment with role responsibilities.
• Adhere to all health and safety protocols as outlined by the organization.

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