Head of Regulatory Affairs

4 weeks ago

London, United Kingdom Northreach Full time
Global Head of Regulatory Affairs

Northreach has partnered with a leading pharma company based in the UK to recruit a Global Head of Regulatory Affairs to lead their regulatory team.

Key Responsibilities:
  • Lead the regulatory team, interfacing with regulatory agencies like the MHRA, EMA, and FDA.
  • Prepare and submit regulatory documents, and manage risk.
  • Develop and implement regulatory strategies while managing local regulatory partners and ensuring robust data management systems are in place.
  • Lead the creation and execution of comprehensive regulatory plans for global markets, ensuring adherence to both local and international regulations.
  • Oversee the preparation, submission, and ongoing management of regulatory documents.
  • Provide cross-functional leadership by coordinating with internal and external teams to ensure alignment with regulatory requirements.
  • Lead and develop the regulatory team, enhancing their knowledge, skills, and capabilities to effectively support the company's strategic objectives.
  • Serve as the primary liaison with regulatory agencies, managing communications and facilitating timely approvals.
  • Monitor global regulatory developments to ensure continuous compliance of products throughout their lifecycle.
  • Identify potential regulatory risks and develop effective mitigation strategies.
  • Lead training and mentorship initiatives within the regulatory affairs team, fostering regulatory expertise and growth within the organization.

Requirements:

  • Extensive background in regulatory affairs within the pharmaceutical, biotech, or medical device industries, with experience in global markets such as the US, EU, and Rest of World (ROW).
  • Comprehensive knowledge of regulatory requirements and guidelines from agencies like the FDA, EMA, and others.

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