Job description
Key Responsibilities:
Develop and implement regulatory strategies for our products in Germany and other markets, 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 commercialization.
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 in Germany, including recruitment, training, and performance management.
Requirements:
Advanced degree in a scientific or related field, with a minimum of 10 years of regulatory affairs experience in the biotech or pharmaceutical industry.
Extensive knowledge of regulatory requirements for drug development and product approvals in Germany and the EU.
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.
Fluent in German and English, with excellent written and verbal communication skills in both languages.
Experience in rare diseases and/or orphan drug development is a plus.
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact George Hebden Lee at +44 (0)20 3854 7700 or George.hebden-lee@mantellassociates.com.
