Senior Manager, Contracts Management
3 days ago
Position Overview: We are seeking an experienced and driven Manager or Senior Manager, Regulatory Affairs specializing in Cell and Gene Therapy to join our team. This role will play a pivotal part in leading regulatory strategies and ensuring the successful approval and post-approval management of cutting-edge cell and gene therapy products. The Senior Manager will collaborate closely with cross-functional teams to ensure compliance with global regulatory requirements, provide strategic regulatory guidance, and interact with regulatory agencies.
Regulatory Strategy Development: Lead the development and execution of comprehensive regulatory strategies for cell and gene therapy products, from early development through approval and life-cycle management, aligning with corporate objectives.
Regulatory Submissions: Manage the preparation, review, and submission of regulatory documents (INDs, BLAs, MAAs, etc.) to health authorities, ensuring that submissions meet all regulatory requirements and timelines.
Serve as the primary point of contact with global regulatory agencies (e.g., FDA, EMA) for assigned products, leading meetings, responding to agency questions, and negotiating on regulatory matters to facilitate product approvals.
Partner with cross-functional teams, including clinical, CMC, quality, and commercial departments, to align on regulatory strategies and ensure coordinated efforts across the product lifecycle.
Compliance and Monitoring: Stay current with evolving regulatory guidelines, particularly those pertaining to cell and gene therapies, and communicate relevant updates to the internal teams. Ensure ongoing compliance with regulatory requirements throughout the product lifecycle.
Risk Management: Identify and evaluate regulatory risks, providing risk mitigation strategies and guidance on how to best approach regulatory challenges in the cell and gene therapy space.
Team Leadership: Lead and mentor junior regulatory staff, fostering a collaborative environment that promotes knowledge sharing and professional development.
Bachelor's degree in life sciences, biotechnology, or a related field (required).
Advanced degree (MS, PhD, PharmD) in a relevant field (preferred).
Minimum of 4-8 years of regulatory affairs experience in the biopharmaceutical industry, ideally with exposure to cell and gene therapy.
Proven track record of leading regulatory submissions and obtaining approvals for advanced therapies (e.g., In-depth understanding of regulatory frameworks for cell and gene therapy products (e.g., Strong project management skills with the ability to manage multiple priorities and deadlines in a fast-paced environment.
Leadership and People Management
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