Global Regulatory Acceleration Strategist
1 month ago
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.
About the RoleThis 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.
Key Responsibilities:- Develop and implement global regulatory strategies for simultaneous marketing authorisation submissions across various regions.
- Identify risks and mitigations to protect business interests and maintain timelines.
- Lead detailed preparation of regulatory plans for individual country filings, ensuring compliance with local regulations.
- Lead global filing teams in generating country-specific datasets and updating core documentation, including adaptation of core dossier contents for country submissions.
- Coordinate filing teams for RTQ generation, providing strategic guidance to address regulators' questions and guide the team to prepare high-quality responses.
- Suggest and coordinate innovative regulatory procedures to increase acceleration opportunities, aligning with the company's ambition to accelerate time for submission, approvals, and accessing markets.
- University degree in a life science industry, preferably with a focus on regulatory affairs.
- 8-15 years of relevant regulatory affairs experience, with extensive knowledge of preparing global filing plans for markets worldwide and awareness of regulatory frameworks in all major markets globally.
- Strong leadership skills and motivation 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, and excellent communication and organizational skills.
- Experience working within a regulatory matrix team in the pharmaceutical industry and fluency in English, written and spoken.
- An estimated annual salary range of $120,000 - $180,000, depending on qualifications and experience.
- A dynamic and supportive work environment that fosters professional growth and development.
- The opportunity to work on high-profile projects with a global impact.
- A competitive benefits package, including health insurance, retirement savings plan, and paid time off.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT, connecting talented professionals with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.
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