Global Regulatory Affairs Strategist

hace 1 semana


Madrid, Madrid, España Parexel A tiempo completo

Parexel's Global Regulatory Acceleration Initiative

We are seeking an experienced Regulatory Affairs professional to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets.

This is an exciting opportunity to play a crucial role in accelerating time to filing and approval in Global Country Initiative (GCI), emerging markets, and non-EU markets.

About the Role:

  • Develop and implement global regulatory strategies for simultaneous marketing authorisation submissions.
  • Identify risks and mitigations to protect business interests and maintain timelines.
  • Lead detailed preparation of regulatory plans for individual country filings.
  • Lead global filing teams in generating country-specific datasets and updating core documentation.
  • Lead adaptation of core dossier contents for country submissions.
  • Coordinate filing teams for RTQ generation, provide strategic guidance to the global filing teams to address regulators' questions and guide the team to prepare high-quality responses.
  • Set up global filing team meetings, draft responses, coordinate reviews and approvals.
  • Suggest and coordinate innovative regulatory procedures to increase acceleration opportunities.
  • Work closely with local and regional regulatory leads on all aspects of marketing review and approvals.
  • Manage routine MA maintenance activities as required.

Qualifications and Experience:

  • University degree in a life science industry.
  • 8-15 years of relevant regulatory affairs experience.
  • Extensive experience in preparing global filing plans for markets worldwide, and awareness of regulatory frameworks in all major markets globally.
  • Strong leadership skills and motivated, to support senior filing teams through marketing applications, overarching CMC, Clinical and Nonclinical.
  • Familiarity with CPPs and timing for filings in various markets.
  • Proficiency in Veeva Vault and other regulatory systems.
  • Excellent communication and organisational skills.
  • Experience working within a regulatory matrix team in the pharmaceutical industry.
  • Fluent in English, written and spoken.

Salary: The estimated salary for this role is £80,000 - £110,000 per annum, depending on experience.

About Parexel:

Parexel is a leading clinical research organisation dedicated to helping clients accelerate time-to-market for new and existing treatments. With a global presence, we offer comprehensive solutions across the entire product development lifecycle.


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