Global Head of Regulatory Affairs

4 days ago

Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Northreach Full time
Global Head of Regulatory Affairs

Northreach is partnering with a leading pharma company in the UK to find a talented Global Head of Regulatory Affairs to lead their regulatory team.

Key Responsibilities:

  • Develop and Implement Regulatory Strategies: Manage local regulatory partners and ensure robust data management systems are in place.
  • Lead Regulatory Planning: Create and execute comprehensive regulatory plans for global markets, ensuring adherence to local and international regulations.
  • Regulatory Document Management: Oversee the preparation, submission, and ongoing management of regulatory documents (e.g., INDs, NDAs, MAAs) to health authorities.
  • Leadership and Team Development: Provide cross-functional leadership, coordinate with internal and external teams, and lead the regulatory team to enhance their knowledge and skills.
  • Regulatory Liaison: Serve as the primary liaison with regulatory agencies, managing communications and facilitating timely approvals.
  • Regulatory Risk Management: Monitor global regulatory developments and identify potential regulatory risks, developing effective mitigation strategies.
  • Training and Mentorship: Lead training and mentorship initiatives within the regulatory affairs team, fostering regulatory expertise and growth.

Requirements:

  • Extensive background in regulatory affairs within the pharmaceutical, biotech, or medical device industries, with experience in global markets.
  • Comprehensive knowledge of regulatory requirements and guidelines from agencies like the FDA, EMA, and others.
  • Proven experience in leading small teams across multiple countries and time zones.
  • Strong expertise in GxP (Good Practice) standards.

If you are interested in this opportunity, please apply with an up-to-date copy of your CV, and we will be in touch.

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