Global Regulatory Affairs Project Leader (m/w/d)
Swiss Life Sciences Recruitment Consultant - Skilled Recruitment Solutions GmbH
Overview
Responsibilities and profile for the Global Regulatory Affairs Project Leader position.
Responsibilities
* Lead and coordinate regulatory projects globally across development and lifecycle phases
* Drive lifecycle management for registered products, including variations, labelling updates, and CMC changes
* Design regulatory strategies tailored to markets including the US, Canada, and Europe
* Liaise with regulatory authorities, such as the EMA, FDA, and Health Canada, managing submissions and interactions
* Collaborate cross-functionally with clinical, technical, and quality teams to ensure alignment on regulatory deliverables
* Prepare and review documentation such as IMPDs, Module 1 content, briefing packages, orphan and pediatric filings, and more
* Monitor regulatory intelligence to keep development programs aligned with evolving guidelines
Profile
* Master’s degree in Life Sciences (e.g. Pharmacy, Biochemistry, Biology)
* 3–5 years of experience in Regulatory Affairs within the pharmaceutical industry
* Strong expertise in lifecycle maintenance and regulatory submissions
* Solid knowledge of major regulatory systems (EU, US, Canada)
* Prior experience coordinating with Health Authorities (EMA/FDA)
* Experience in regulatory project ownership on the sponsor side is a plus
* Hands-on mindset with excellent communication and organizational skills
* Fluency in English (spoken and written)
Seniority level
* Associate
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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