Regulatory Affairs Manager

Vor 6 Tagen

Luzern, Schweiz Ekkiden Vollzeit

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 regulatory reinforcement for a leading international pharmaceutical company, we are seeking a Regulatory Affairs Manager with strong expertise in Swiss market authorizations to support the life cycle management and compliance of medicinal products in Switzerland.

**Responsabilities**:

- Develop and implement regulatory strategies for **marketed and new pharmaceutical products in Switzerland**.
- Prepare, submit, and manage regulatory dossiers (new submissions, variations, renewals) with **Swissmedic**.
- Ensure ongoing compliance of products with Swiss regulatory requirements throughout their life cycle.
- Serve as the point of contact with **Swissmedic**and handle regulatory correspondence.
- Collaborate closely with cross-functional teams: Quality, R&D, Pharmacovigilance, Supply Chain.
- Monitor regulatory developments in Switzerland and ensure timely implementation of updates internally.

What we are looking for:
**Education**:

- University degree in Pharmacy, Life Sciences, or a related field.

**Experience**:

- At least 5 years of experience in regulatory affairs within the **pharmaceutical industry**(excluding medical devices).
- Proven knowledge of **Swiss regulatory environment**and procedures with **Swissmedic**.
- Familiarity with eCTD submissions, ICH guidelines, and local Swiss legislation (e.g., LPTh, OAMéd).

Languages:

- ** Fluent German**(working language on site).
- ** Professional English**(spoken and written) is mandatory.
- French

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?**

**Initial Call**:Our recruitment team will reach out to discuss your motivations and expectations.

**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

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