Regulatory Affairs Manager H/F Ekkiden

Détail du poste

International consulting group founded in 2019, Ekkiden fosters an ecosystem of passionate and committed consultants who lead organizational, operational, and technological transformation projects in IT/Digital, Industry/R&D, and Sustainability, for large enterprises and SMEs in France, Switzerland, Spain, and Germany.

About the job
As part of a strategic reinforcement of our regulatory activities, we are looking for a Regulatory Affairs Manager with strong expertise in Swiss market authorizations to support the life cycle management , Swissmedic interactions , and pharmacovigilance compliance for medicinal products in Switzerland.
This role is key to ensuring full compliance with Swiss-specific regulations , and managing the regulatory interface with Swissmedic through platforms such as Elvis .
Responsabilities :
- Define and implement regulatory strategies for both marketed and new medicinal products in Switzerland
- Prepare, submit, and manage regulatory dossiers (new submissions, variations, renewals) in coordination with Swissmedic
- Ensure regulatory compliance across the product life cycle in line with Swiss national legislation (e.g., LPTh, OAMéd)
- Serve as main point of contact with Swissmedic and handle all local regulatory correspondence
- Monitor and interpret local regulatory developments and implement necessary updates internally
- Collaborate with cross-functional teams : Quality, R&D, Pharmacovigilance, and Supply Chain
- Support pharmacovigilance activities , including review and management of adverse drug reactions (EIM) and interactions with safety teams
- Ensure correct usage of Swiss-specific regulatory platforms (e.g., Elvis )

What we are looking for :

Education
- University degree in Pharmacy, Life Sciences, or a related discipline

Experience
- Minimum 5 years of experience in regulatory affairs within the pharmaceutical industry (excluding medical devices)
- Proven track record with Swissmedic submissions and the Elvis platform
- Experience in pharmacovigilance or strong medical background enabling the management of adverse event reports (EIM)
- Excellent understanding of Swiss-specific regulatory procedures (not limited to EU/global frameworks)
- Familiarity with eCTD , ICH guidelines , and Swiss regulations (LPTh, OAMéd)

Languages
- Fluent German (working language on site)
- Professional English (spoken and written)
- French is a strong plus

We offer :

Join us at the right time to make your mark in a fast-growing organization

Various missions and projects that will allow you to have a real impact on the company

The ability to work autonomously and to drive new initiatives

A career path adapted to your personality, both in terms of role and location

A strong culture, based on sharing, respect, ambition, and team spirit

The opportunity to manage teams and develop your area of expertise by leading one of our squads

Develop your management and leadership skills, because, at Ekkiden, consultants look after the careers of other consultants. Gone are the days when your career was driven by a salesman !

Health insurance

What's the Recruitment Process Like at Ekkiden?

At Ekkiden, we're committed to providing a positive experience for every candidate.
Initial Call : Our recruitment team will reach out to discuss your motivations and expectations. Interviews : You'll have one or two interviews with our business managers, depending on the role you're applying for. Client Meeting : Finally, you'll have the opportunity to meet with the client.
While this is our standard process, we may make adjustments based on specific circumstances.

You can also find all our job offers on our website
https://jobs.ekkiden.com/