Regulatory Affairs Manager (H/F/X)
Regulatory Affairs Manager (H/F/X)
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Job Description
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 aRegulatory Affairs Manager with strong expertise in Swiss market authorizations to support the life cycle management and compliance of medicinal products in Switzerland.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 OAMd).
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
Theabilityto work autonomously and todrive new initiatives
A career path adapted to your personality both in terms of role andlocation
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 skillsbecause atEkkiden consultants look after the careers of other consultants. Gone are the days when your careerwasdriven by a salesman!
Health insurance
Whats the Recruitment Process Like at Ekkiden
At Ekkiden were committed to providing a positive experience for every candidate.
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
Experience:
Manager
Employment Type
Full-Time
Key Skills
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