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.

All the best,

Taylor