Head of Regulatory Affairs

3 weeks ago

Bristol, Bristol, United Kingdom DNA Life Sciences Full time

Key Responsibilities:

  • Oversee and coordinate 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 strategic regulatory guidance and operational assistance on a global scale.
  • Author, review, and manage essential regulatory documents for submission to regulatory authorities.
  • Support the planning and implementation of regulatory strategies to ensure successful product development, including contributions to development plans and Target Product Profiles.
  • Assist in the creation of cGMP manufacturing processes and controls, and prepare regulatory documentation for GMP inspections.
  • Maintain the regulatory document management system and ensure compliance, including the drafting 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 the development of small molecules and biologics.
  • Proven expertise in drafting key regulatory documents such as Clinical Trial Applications (CTAs), Investigational New Drug applications (INDs), and development plans.
  • Comprehensive knowledge of GXP across development functions, ICH guidelines, and relevant regulations.
  • Exceptional organizational, analytical, planning, and project management skills, with experience in overseeing external regulatory providers.
  • Demonstrated ability to engage with key regulatory agencies and a thorough understanding of evolving guidelines and regulatory trends.

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