EU Regulatory Strategy Lead – Global Projects

1100 Mylan Pharmaceuticals Inc.; Schweiz; Hybrid; CHF 140.000 - 200.000; Vollzeit

Benefits dieser Stelle

Home office up to 2 days/week

Development opportunities

Zusammenfassung

Viatris is seeking an EU Senior Global Regulatory Affairs Project Leader to define and drive EU regulatory strategies in alignment with global development plans. You will lead interactions with EMA and national authorities, prepare scientific advice, and oversee submissions across life-cycle activities.

The role requires extensive EMA/NCA experience, a strong clinical development background, and excellent communication skills, with fluency in English.

Qualifikationen

• 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).

Aufgaben

• 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.
• Coordinate global submission planning and execution.

Kenntnisse

Master’s degree

8+ years Regulatory Affairs

EU regulatory strategy

EMA/NCA experience

Clinical development knowledge

Communication & stakeholder mgmt

English fluency

Ausbildung

Master’s degree in Life Sciences or related

Jobbeschreibung

Viatris is seeking an EU Senior Global Regulatory Affairs Project Leader to define and drive EU regulatory strategies in alignment with global development plans. You will lead interactions with EMA and national authorities, prepare scientific advice, and oversee submissions across life-cycle activities.

The role requires extensive EMA/NCA experience, a strong clinical development background, and excellent communication skills, with fluency in English.