Lead Regulatory Strategy Officer

3 weeks ago


Bristol, Bristol, United Kingdom DNA Life Sciences Full time

Key Responsibilities:

  • Oversee and strategize all regulatory initiatives across the product range.
  • Serve as the primary regulatory liaison, collaborating with both internal teams and external partners.
  • Develop Requests for Proposals and outline the scope of services for outsourced regulatory functions.
  • Manage the evaluation and selection process for external regulatory service providers.
  • Provide comprehensive global regulatory strategic guidance and operational assistance.
  • Author, review, and manage essential regulatory documents for submission to regulatory authorities.
  • Contribute to the planning and execution of regulatory strategies to ensure successful product development, including the drafting of development plans and Target Product Profiles.
  • Support the creation of current Good Manufacturing Practices (cGMP) processes and controls, and prepare regulatory submissions for GMP audits.
  • 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 abreast of industry trends.

Required Skills and 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 key regulatory documents such as Clinical Trial Applications (CTAs), Investigational New Drug applications (INDs), and development plans.
  • Thorough knowledge of Good Practice (GXP) standards across development functions, as well as ICH guidelines and relevant regulations.
  • Exceptional organizational, analytical, planning, and project management skills, with experience in overseeing external regulatory providers.
  • Demonstrated capability to engage with key regulatory agencies and a solid understanding of evolving guidelines and regulatory trends.


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