Director Global Regulatory Affairs (m/f/d)

Company Overview :

Full-Life Technologies Limited (Full-Life) is a fully integrated, fast-growing radiotherapeutics company with operations in Belgium, Germany, and China.

The company is a pioneer in the development of radiopharmaceuticals for cancer treatment through accelerating innovations in radio-isotope supply, manufacturing technology and cancer biology.

Full-Life seeks to own the entire value and supply chain for radiopharmaceutical research, development, production, regulatory approval and commercialization in order to deliver clinical impact for patients.

The Company endeavors to tackle fundamental challenges affecting radiopharmaceuticals today by pioneering innovative research that will shape the treatments of tomorrow.

We are comprised of a team of fast-moving entrepreneurs and seasoned scientists with a proven history of success in the life sciences, alongside radioisotope research and clinical development.

Our team is rapidly growing on a global scale, currently encompassing over 60 full-time professionals.

Since Inception, Full-Life has completed Seed, Series A and Series B financing and secured more than $110 million funding.

The Company has also completed an acquisition with total deal value of $245 million in 2023. Learn more at : www.full-life.com .

Summary :

The Director of Global Regulatory Affairs (m / f / d) plays a critical role in the successful development and commercialization of FL oncology portfolio.

As the business impact is substantial, we are looking for a strategist with 10+ years of experience in R&D Oncology. This role serves as a strategic regulatory advisor to the cross-functional team and as Regulatory KOLs liaison, ensuring successful registration of FL s oncology development assets.

Key Responsibilities :

Regulatory Strategy Development :

• Develop and implement regulatory strategies
• Provide regulatory guidance to product development teams from early development through post-marketing.
• Ensure an understanding of the external regulatory competitive environment to adapt product regulatory strategy accordingly.
• Provide an assessment of regulatory opportunities to potentially enhance the development pathway and of the regulatory risks for the various options for regulatory development, as well as potential measures for risk mitigation.

Regulatory Submissions and Approvals :

• Lead the preparation of regulatory documents and ensure timely submission and approval
• Manage interactions with regulatory agencies, including responding to inquiries and deficiency letters.

Compliance and Monitoring :

• Monitor and interpret regulatory developments and trends, assessing their impact on the company.
• Ensure compliance with applicable regulations and standards throughout the product lifecycle.
• Develop and maintain regulatory standard operating procedures (SOPs).

Cross-functional Collaboration :

• Collaborate with R&D, Quality Assurance, Project Management and other departments.
• Provide regulatory training and support to internal teams.
• Manage external regulatory vendors and service providers.

Documentation and Record-keeping :

• Maintain comprehensive and up-to-date regulatory files and records.
• Ensure all regulatory documentation is accurate, complete, and submitted on time.

Qualification requirements and skills :

• 10+ years’ experience in R&D Oncology or 3+ years’ experience at Regulatory Agencies as a clinical assessor.
• 6+ years in global regulatory experience in big pharma as a strategist.
• Experience as a Global Regulatory Lead
• Proven track record of successful regulatory submissions and approvals.
• In-depth knowledge of pharmaceutical law and awareness of current trends in Regulatory Affairs
• Solid knowledge and understanding of complex medical and scientific subject matter, as well as evolving regulatory policy and guidance
• Experience in speaking at external meetings and acting as a company representative on pharmaceutical industry committees is highly desirable.

Soft skills :

• Strong leadership and decision-making abilities.
• Ability to thrive in a fast-paced, dynamic environment.
• Excellent problem-solving and analytical skills.
• Adaptability and flexibility to changing priorities and deadlines.
• Ability to think outside of the box is crucial
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
• Good organizational and planning skills.

Education :

• Pharmacist and / or Medical Doctor
• Advanced degree in Pharmaceutical Law (e.g. RAC, DGRA, Master of Laws), Clinical Pharmacology or Health-economics is a plus

Preferably located close to Heidelberg.