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Director of Regulatory Excellence

2 months ago

Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time
Job Description

Job Title: Director, Global Regulatory Affairs, Oncology

Job Summary:

We are seeking a highly experienced and skilled Director, Global Regulatory Affairs, Oncology to join our team at Lifelancer. As a key member of our organization, you will be responsible for developing and executing regulatory strategies for our assigned programs and products.

Key Responsibilities:

  • Regulatory Strategy Development: Develop and execute regulatory strategies for assigned programs and products, ensuring compliance with regulatory requirements and industry standards.
  • Regulatory Intelligence: Continuously monitor the scientific evolution of assigned diseases and incorporate external environment into plans.
  • Regulatory Due Diligence: Conduct regulatory due diligence assessments on external opportunities.
  • Regulatory Communication: Ensure timely and accurate information of regulatory developments to all stakeholders.
  • Regulatory Budgeting: Contribute towards effective planning of the GRA budget.
  • Regulatory Ethics and Compliance: Ensure all activities are conducted in line with Ipsen's ethics and compliance policies.

Requirements:

  • Experience: Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies.
  • Education: Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences).
  • Skills: Significant experience in the pharmaceutical industry, including minimum 10 years in Regulatory Affairs.

What We Offer:

We offer a dynamic and challenging work environment, competitive compensation and benefits package, and opportunities for professional growth and development.