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Global Head of Regulatory Affairs

2 months ago

London, Greater London, United Kingdom Northreach Full time
Job Overview

Northreach is partnering with a leading pharma company in the UK to find a seasoned Global Head of Regulatory Affairs. This role will oversee the regulatory team, ensuring compliance with global regulations and facilitating effective communication with regulatory agencies.

Key Responsibilities:

  • Develop and implement regulatory strategies, collaborating with local regulatory partners to ensure robust data management systems are in place.
  • Lead the creation and execution of comprehensive regulatory plans for global markets, adhering to both local and international regulations.
  • Oversee the preparation, submission, and ongoing management of regulatory documents (e.g., INDs, NDAs, MAAs) to health authorities such as the MHRA, FDA, EMA, and others.
  • 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.
  • Proven experience in leading small teams across multiple countries and time zones.
  • Strong expertise in GxP (Good Practice) standards.

If you are interested in learning more about this opportunity, please submit your updated CV for review.