17 Oct
PAREXEL
Great Britain
Job description
When our values align, there's no limit to what we can achieve.
We are seeking experienced Regulatory Affairs professionals 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.
Our global regulatory teams are well supported to prioritise our major markets filings and are targeting high quality simultaneous filings with Stringent Regulatory Authorities (SRAs)as well as rest of world markets.
Our ambition is to accelerate the time for submission, approvals and accessing markets,
and this role’s mission will be to help realise this ambition.
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