Global Program Lead, Global Regulatory Affairs

Posted 2 years ago

Key responsibilities:

  • Lead, develop and implement the global RA strategy for assigned project.
  • Represent RA in Project Teams and in various other cross-functional teams, such as Clinical Study Teams
  • Present and defend regulatory plans to internal governance bodies
  • Represent as the primary interface for FDA/EMA/other Regulatory Agencies on assigned projects, including coordinating and leading meetings with these Agencies.
  • Be accountable for the preparation of submissions in several jurisdictions, such as: INDs/CTAs, Briefing Documents to support meetings with Regulatory Agencies, Orphan Drug Applications, PIP/PSP, Fast Track / Breakthrough Designation/PRIME, etc
  • Work closely with functional experts to coordinate their contributions to regulatory documents
  • Review and approve documents of regulatory relevance such as Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, DSURs, etc
  • Manage and oversee external vendors, such as CROs
  • Contribute to the assessment of new in-licensing opportunities and represents RA in out-licensing teams
  • Maintains knowledge of global competitive and regulatory landscape
  • Contribute to the assessment of the impact that changes might have on assigned projects
  • Contribute to establishing and revising standard operational procedures to maximize the efficiency of processes and ensure compliance to regulations.
  • Leads regulatory sub-teams, as appropriate.
  • Coaches junior RA professionals and may have line function management responsibilities.

Your profile:

  • Bachelor’s degree in life-sciences; a higher degree is preferred
  • At least 10 years of regulatory affairs experience in the field of innovative new drugs, preferably in oncology or anti-infectives, with thorough knowledge of the overall drug development process. Experience with regulatory strategies for life-cycle management is an additional asset.
  • Demonstrated experience with:
    • Development and implementation of regulatory strategies for innovative new drugs, from pre-clinical stages up to registration.
    • Experience with NDA/MAA submissions or post-marketing activities is an additional asset
    • Leading cross-functional teams for preparation of regulatory deliverables
    • Various regulatory procedures in the U.S. and Europe; experience with regulatory procedures in other jurisdictions is an additional asset
    • Managing and overseeing regulatory activities for global clinical trials up to phase III.
    • Leading meetings with Regulatory Agencies
    • You are independent, results driven, team-oriented with the ability to work in cross-functional teams within a matrix organization
    • Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously
    • Demonstrate excellent written and verbal communication skills in English

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