Senior Regulatory Affairs Consultant - MAAs Global Acceleration Initiative

October 16

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Description

• 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 question 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

Requirements

• 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