Regulatory Affairs Manager (all genders)

Merck Healthcare; Zug; Vor Ort; CHF 140.000 - 180.000; Vollzeit

Zusammenfassung

Merck Healthcare in Zug is seeking a Regulatory Affairs Manager on a fixed-term basis to support the maternity leave covering 1 January 2027 to 31 March 2028. You will lead regulatory submissions strategy for new medicinal products and lifecycle management while ensuring compliance with local laws and guidelines.

The role requires collaboration with Head Regulatory Affairs, global teams, and authorities, with deep focus on promotional material review and regulatory strategy.

Qualifikationen

• University degree in pharmacy, medicine or natural sciences.
• At least 5 years' experience in regulatory affairs in Switzerland.
• Analytical and strategic mindset.
• Able to work independently with commitment and accuracy.
• Flexible and able to work under pressure.
• Team player with strong stakeholder interaction.
• Fluent in German with very good English skills.
• Experience with e-CTD submissions and review of promotional materials is a plus.

Aufgaben

• Lead the submission strategy for marketing authorization of new medicinal products.
• Oversee lifecycle management of currently registered products.
• Ensure regulatory tasks comply with external and internal regulations, guidelines and legal bases.
• Coordinate with authorities and internal/external SMEs for efficient collaboration.

Kenntnisse

Regulatory affairs experience

Analytical mindset

Independent working

Team collaboration

Stakeholder management

German language

English language

Ausbildung

University degree in pharmacy, medicine or natural sciences

Jobbeschreibung

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

At our location in Zug we are looking for a qualified person as Regulatory Affairs Manager (all genders) to support the local Regulatory Team. This is a fixed-term position from 1.1.2027 to 31.03.2028 to cover a maternity leave.

Your Tasks

In this position you will be responsible, in consultation with the Head Regulatory Affairs and Global Regulatory Affairs, for the submission strategy of marketing authorization application for new medicinal products as well as for the life cycle management of currently registered medicinal products. You will ensure the successful, competent, diligent and timely fulfilment of all regulatory tasks for the portfolio assigned to you including the correct implementation of and compliance with external and internal regulations, guidelines and legal bases with regards to the registration of medicinal products. Furthermore, you take care of the regulatory review of promotional materials and ensure compliance of the material with local laws and the pharmacode. In this function, you maintain contacts with the authorities as well as internal and external subject matter experts and ensure constructive and efficient cooperation and communication.

Your Pofile

• You have a university degree in pharmacy, medicine or natural sciences.
• You have at least 5 years' experience in regulatory affairs in Switzerland.
• You have an analytical and strategic mindset.
• You are used to work independently, you show commitment and you are detail-oriented.
• You are flexible and able to work under pressure.
• You enjoy working in a team and you are motivated to interact with internal and external stakeholders.
• You are fluent in German and have very good English skills.
• Experience with e-CTD submissions and review of promotional materials are an advantage.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!