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) 
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