Regulatory Affairs Director for Complex Products

hace 1 día


Barcelona, Barcelona, España Alexion Pharma Spain A tiempo completo

Overview: Alexion Pharma Spain seeks a seasoned Regulatory Affairs Management Director to lead our team in developing and implementing regulatory strategies for assigned products and jurisdictions.

Salary Range: €120,000 - €150,000 per annum

Job Description:

Leading the Way in Rare Diseases

We are looking for an experienced Regulatory Affairs Management Director to join our team at Alexion Pharma Spain. As a key member of our Global Regulatory Affairs team, you will be responsible for leading a team of regulatory affairs managers (RAMs) to develop and implement regulatory strategies for assigned products and regulatory jurisdictions.

Responsibilities:

  • Lead a team of RAMs to develop and implement regulatory strategies for products and/or projects in relevant regulatory jurisdictions, aligned to overall Enterprise objectives and global regulatory strategies through initial registration and subsequent lifecycle management.
  • Provide advice and input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
  • Collaborate with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight and broader drug development expertise.
  • Stay up-to-date on latest regulatory requirements and trends, serving as the Subject Matter Expert (SME) and providing guidance on major processes/platforms optimization where required.
  • Work with cross-functional and other regulatory partners to proactively identify areas of risk and improvement, as applicable.
  • Drive knowledge management by sharing case studies/lessons learned from regulatory activities within the Regulatory Science & Execution.
  • Ensure exemplary behavior, leadership, ethics, and transparency within the Enterprise, with Health Authorities and other external stakeholders.

Requirements:

  • A minimum of 10 years of Regulatory experience in the pharmaceutical industry, with experience in regional regulatory strategies.
  • Strong knowledge of drug development and regulatory policy, coupled with excellent scientific and business judgment.
  • The ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
  • The ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.


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