Senior Manager Regulatory Affairs

13 hours ago

UK, UK, United Kingdom Discover International Full time

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.

Key Responsibilities:

  • 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.
  • Agency Interactions: 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.
  • Cross-functional Collaboration: 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.

Qualifications:

Education:

  • Bachelor's degree in life sciences, biotechnology, or a related field (required).
  • Advanced degree (MS, PhD, PharmD) in a relevant field (preferred).

Experience:

  • 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., INDs, BLAs, MAAs).
  • Extensive experience interacting with major global health authorities (FDA, EMA, etc.).

Knowledge and Skills:

  • In-depth understanding of regulatory frameworks for cell and gene therapy products (e.g., FDA's Regenerative Medicine Advanced Therapy (RMAT), EMA's ATMP).
  • Familiarity with CMC, nonclinical, and clinical development processes specific to cell and gene therapies.
  • Strong project management skills with the ability to manage multiple priorities and deadlines in a fast-paced environment.
  • Excellent communication, negotiation, and leadership skills with the ability to collaborate across diverse teams.


Key Competencies:

  • Strategic Thinking and Decision Making
  • Leadership and People Management
  • Problem Solving and Critical Thinking
  • Effective Communication and Negotiation Skills
  • Adaptability and Flexibility in a Fast-paced Environment

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