EU Senior Global Reg Affairs Project Leader (m/f/d)

1100 Mylan Pharmaceuticals Inc.; Schweiz; Vor Ort; 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

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 (m/f/d) 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 biotechExpert 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)

What We Offer

• Friendly working atmosphere in our great office premises in Allschwil
• Home office option up to 2 days per week
• Development opportunities within an international company
• At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
• You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

Why Viatris?

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace,

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be.

If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve.

To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

Bei Viatris, bieten wir wettbewerbsfähige Gehälter, Sozialleistungen und ein integratives Umfeld, in dem Sie Ihre Erfahrungen, Perspektiven und Fähigkeiten einsetzen können, um das Leben anderer zu beeinfluss. Viatris ist ein globales Gesundheitsunternehmen, das 2020 durch die Fusion von Mylan und Upjohn, einem früheren Unternehmensbereich von Pfizer, entstanden ist. Durch die Verbindung der Stärken beider Unternehmen mit etwa 45.000 Beschäftigten weltweit streben wir an, den Zugang zu kostengünstigen, qualitativ hochwertigen Medikamenten für Patienten weltweit, unabhängig von ihrem Wohnort oder ihren Lebensbedingungen, zu erleichtern. Wir glauben an ein Gesundheitswesen, wie es sein sollte – damit Menschen weltweit in jeder Lebensphase gesünder leben können. Basierend auf unserer unerschütterlichen Überzeugung, dass ein verbesserter Zugang auch zu einer besseren Gesundheit führt, setzen wir unser erstklassiges wissenschaftliches Fachwissen und Produktions-Know-how sowie unsere bewährten kommerziellen Fähigkeiten optimal ein, um Patienten hochwertige Medikamente bereitzustellen, wann und wo auch immer sie diese benötigen.