EU Senior Global Regulatory Affairs Project Leader- 6943
Our client is headquartered in Switzerland – a biotech‑hub of Europe – is a high‑potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options is looking a EU Senior Global Regulatory Affairs Project Leader for a initial 2 years contract based in Basel.
The EU Senior Global Regulatory Affairs (RA) Project Leader provides strategic regulatory leadership for the development, approval, and life‑cycle management of innovative medicinal products across Europe. The role partners closely with global cross‑functional teams and acts as a key interface with the European Medicines Agency (EMA) and EU National Competent Authorities to enable timely, compliant regulatory pathways.
Main Responsibilities:
Define and execute EU regulatory strategies in alignment with global development plans
Serve as primary EU regulatory contact with EMA and coordinate interactions with National Competent Authorities
Lead preparation and execution of Scientific Advice, regulatory meetings, and related briefing packages
Oversee EU regulatory submissions including IMPDs, PIPs, Orphan Drug Applications, MAAs, variations, and life‑cycle updates
Ensure EU labeling compliance and alignment with the Company Core Data Sheet
Represent Regulatory Affairs on cross‑functional project and governance teams
Maintain regulatory intelligence and assess impact of new guidance and regulations
Contribute regulatory expertise to due diligence and business development activities
Develop and lead global regulatory strategies and Regulatory Functional Plans
Coordinate global submission planning and execution
Own creation and maintenance of the global Company Core Data Sheet
Lead regulatory sub‑teams and ensure delivery of regulatory milestones
Support affiliates and partners with global regulatory strategy and execution Qualifications and Experience:
Relevant Swiss working/residency permit and/or Swiss/EU‑Citizenship required; Master’s degree (or equivalent) in Life Sciences or related discipline
8+ years of Regulatory Affairs experience within pharma or biotech
Expert knowledge of EU, ICH, and global regulatory frameworks
Extensive experience working with EMA and EU National Competent Authorities
Strong understanding of clinical development and regulatory life‑cycle activities
Excellent communication, stakeholder management, and project leadership skills
Fluent English (written and spoken) #J-18808-Ljbffr