EU Senior Global Regulatory Affairs Project Leader

About the role

The EU Senior Global Regulatory Affairs Project Leader will define and execute EU regulatory strategies, acting as the primary liaison with EMA and national authorities to ensure successful product development and market access across Europe.

Key responsibilities

• Define and execute EU regulatory strategies aligned with global development plans.
• Lead preparation and execution of scientific advice, regulatory meetings and briefing packages.
• Oversee EU regulatory submissions including IMPDs, PIPs, orphan drug applications, MAAs and lifecycle updates.
• Maintain regulatory intelligence and assess impact of new guidance.
• Represent Regulatory Affairs on cross‑functional project and governance teams.

Required profile

• Master’s degree in Life Sciences or related discipline.
• 8+ years of regulatory affairs experience in pharma or biotech.
• Expert knowledge of EU, ICH and global regulatory frameworks.
• Extensive experience working with EMA and EU national competent authorities.
• Fluent English, both written and spoken.

Required skills

• Regulatory strategy development.
• EU submission preparation (IMPD, PIP, MAA, etc.).
• Regulatory intelligence and guidance interpretation.
• Stakeholder management with health authorities.

What we offer

• Friendly working atmosphere in Allschwil office.
• Home‑office option up to two days per week (hybrid work mode).
• Development opportunities within an international company.
• Competitive salary and benefits, inclusive environment.