Regulatory Affairs Expert

1 day ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Planet Pharma Full time
About the Job

We are seeking a highly experienced Director EU Regulatory Strategy to join our team at Planet Pharma. This is a temporary position for an initial 6 months, working fully remote in the UK.

The ideal candidate will have a proven track record of leading successful engagements with the EMA and deep understanding of EU regulatory requirements.

Responsibilities:

  • Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., IND, briefing documents, DSUR, BLA)
  • Identify regulatory risks and opportunities and work with key stakeholders to develop solutions
  • Maintain currency of EU regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance
  • Monitor and analyze global and country specific regulatory landscape to assess potential impact on the program; collaborate with teams to ensure compliance
  • Provide support to local regulatory experts in Rest of World to support applications and reviews.

Requirements:

  • Education in life sciences required
  • Proven experience in biopharmaceutical industry with deep understanding of EU regulatory requirements
  • Demonstrated experience of leading successful engagement with EMA
  • Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred.
  • Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills
  • Strong written, verbal communication skills, and interpersonal skills
  • Capable of managing shifting priorities in a rapidly changing environment
  • Ability to travel domestically and internationally (~10%)

Estimated Salary: £85,000 - £120,000 per annum, depending on experience.



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