Vice President of Regulatory Strategy

3 weeks ago


Bristol, Bristol, United Kingdom DNA Life Sciences Full time

Position Overview:

The Director of Regulatory Strategy at DNA Life Sciences will play a pivotal role in overseeing and orchestrating all regulatory initiatives across our diverse product range. This position requires a strategic thinker who can effectively collaborate with both internal teams and external partners.

Key Responsibilities:

  • Oversee and coordinate all regulatory activities associated with the product portfolio.
  • Serve as the primary regulatory liaison, facilitating communication between internal departments and external stakeholders.
  • Develop Requests for Proposals (RFPs) and outline the scope of services for outsourced regulatory functions.
  • Evaluate and select external regulatory service providers.
  • Provide comprehensive global regulatory strategic guidance and operational support.
  • Author, review, and manage essential regulatory documents for submission to regulatory authorities.
  • Contribute to the formulation and execution of regulatory strategies to ensure successful product development, including drafting development plans and Target Product Profiles.
  • Support the establishment of current Good Manufacturing Practices (cGMP) processes and controls, preparing necessary regulatory documentation for GMP inspections.
  • Maintain the regulatory document management system and ensure compliance through the creation and upkeep of key regulatory Standard Operating Procedures (SOPs).
  • Engage in regulatory intelligence activities to stay informed on industry trends.

Qualifications:

  • A minimum of a Bachelor's degree in a life science, medical, or related discipline.
  • At least 8 years of experience in regulatory affairs.
  • Strong understanding of global regulatory standards for small molecules and biologics development.
  • Proven expertise in drafting critical regulatory documents, including Clinical Trial Applications (CTAs), Investigational New Drug applications (INDs), and development plans.
  • In-depth knowledge of Good Practice (GXP) regulations, ICH guidelines, and relevant regulations.
  • Exceptional organizational, analytical, planning, and project management skills, with experience in managing external regulatory partners.
  • Demonstrated capability to interact with key regulatory agencies and a thorough understanding of evolving guidelines and regulatory trends.


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