Mantell Associates
Mantell Associates is currently partnered with a leading CDMO organisation in their search for a Global Head of Regulatory Affairs to join their growing team.
Global Head of Regulatory Affairs – Responsibilities:
- Develop and implement regulatory strategies, ensuring compliance with local regulations and guidelines
- Lead and manage regulatory submissions for clinical trials and product approvals, including interactions with regulatory agencies, consultants, and partners
- Build and maintain relationships with regulatory authorities, key opinion leaders, and industry associations
- Provide strategic advice to cross-functional teams on regulatory requirements and timelines for product development and commercialisation
- Ensure the company’s quality system is in compliance with regulatory requirements, and lead regulatory inspections
- Stay up-to-date with regulatory developments and trends in the biotech industry and provide guidance to the company on emerging regulatory issues
- Manage and develop the regulatory affairs team, including recruitment, training, and performance management
Global Head of Regulatory Affairs – Requirements:
- Advanced degree in a scientific or related field, with strong regulatory affairs experience in the biotech or pharmaceutical industry
- Extensive knowledge of regulatory requirements for drug development and product approvals
- Proven track record in successful interactions with regulatory authorities and successful regulatory submissions
- Strong leadership and people management skills, with experience leading and developing regulatory affairs teams
- Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders
- Strong analytical and problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at 44 (0)20 3854 7700.