EU Senior Global Reg Affairs Project Leader

EU Senior Global Reg Affairs Project Leader

Viatris

Allschwil, Switzerland

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the EU Senior Global Reg Affairs Project Leader role will make an impact:

• 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.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• 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).