Global Regulatory Affairs Director

Vor 4 Tagen

Heidelberg, Baden-Württemberg, Deutschland Full-Life Technologies Vollzeit
About the Role

We are seeking a highly experienced and skilled Director of Global Regulatory Affairs to join our team at Full-Life Technologies. As a key member of our organization, you will play a critical role in the successful development and commercialization of our oncology portfolio.

Key Responsibilities
  • Regulatory Strategy Development:
    • Develop and implement regulatory strategies to ensure compliance with applicable regulations and standards.
    • 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.
Requirements
  • 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.
Preferred Qualifications
  • 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.
Location

Preferably located close to Heidelberg.

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