Regulatory Affairs Manager H/F chez Ekkiden
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.- FrenchWe offer :Join us at the right time to make your mark in a fast-growing organizationVarious missions and projects that will allow you to have a real impact on the companyThe ability to work autonomously and to drive new initiativesA career path adapted to your personality, both in terms of role and locationA strong culture, based on sharing, respect, ambition, and team spiritThe opportunity to manage teams and develop your area of expertise by leading one of our squadsDevelop 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 insuranceWhat’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/