TI - Global Regulatory Affairs Director

Northreach have partnered with an exciting pharma company based in the UK that are recruiting for a Global Head of Regulatory Affairs to join their team. The role will lead the regulatory team, interfacing with regulatory agencies like the MHRA, EMA, FDA, preparing and submitting regulatory documents, and managing risk. The role requires a deep understanding of global regulations, excellent leadership skills, experience working with CMO partners and extensive knowledge of drug development.

Key Responsibilities:

• 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 (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.

Experience

• 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 hearing more, please apply with an up to date copy of your CV and I will be in touch.