Global Head of Regulatory Affairs

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

Seniority level

Director

Employment type

Full-time

Job function

Research, Science, and Strategy/Planning

Industries

Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing