Senior Regulatory Affairs Consultant
hace 4 semanas
Accelerating Time to Filing and Approval
Parexel is seeking an experienced Regulatory Affairs professional to support 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.
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 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
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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