Regulatory Affairs Expert

4 settimane fa


Milano, Lombardia, Italia Parexel A tempo pieno

Unlocking Global Opportunities

Parexel is 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 role will play a crucial part in accelerating time to filing and approval in Global Country Initiative (GCI), emerging markets, and non-EU markets.

Our global regulatory teams are well-supported to prioritize major markets filings and target high-quality simultaneous filings with Stringent Regulatory Authorities (SRAs) as well as rest of world markets.

Key Responsibilities:

  • 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 the 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 the 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 organizational skills
  • Experience working within a regulatory matrix team in the pharmaceutical industry
  • Fluent in English, written and spoken

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