Expert Medical Regulatory Writer

Sanofi UK

Barcelona, Spain
Base: €60,000.00 - €80,000; bonus/equity: not spec...
Hybrid
8+ years regulatory writing experience
Expert knowledge of ctd submissions
Clinical study report (csr) authoring
The role involves leading complex clinical submissions and delivering high-quality documents like CSRs and PBRERs to regulatory authorities

Job Summary

  • The role involves leading complex clinical submissions and delivering high-quality documents like CSRs and PBRERs to regulatory authorities.
  • Candidates will act as a subject matter expert, mentoring peers and collaborating with global clinical and safety teams.
  • Sanofi offers a competitive salary range of €60,000.00 - €80,000 for this permanent full-time position in Barcelona.

Matching Summary

The role involves leading complex clinical submissions and delivering high-quality documents like CSRs and PBRERs to regulatory authorities.

Salary

Base: €60,000.00 - €80,000; Bonus/Equity: Not specified; Benefits: Company employee benefit programs eligible

Skills & Requirements

Must-have

  • 8+ years regulatory writing experience
  • Expert knowledge of CTD submissions
  • Clinical Study Report (CSR) authoring
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Risk Management Plan (RMP) development

Nice-to-have

  • Mentoring junior medical writers
  • Cross-therapeutic area agility
  • Stakeholder management skills
  • Independent project leadership

Key Requirements

  • Minimum 8 years pharmaceutical regulatory writing experience
  • Advanced degree in life sciences, pharmacy, or medicine
  • Expertise in global drug registration processes

Work Rights

Not specified

Tailored Resume

Cover Letter