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Senior Consultant at STR Group AG | Partnering with Businesses in Switzerland for Talent Acquisition & Growth
Regulatory Affairs Specialist
Location: Neuchâtel, Switzerland (On-site presence required)
Employment Type: Full-time (permanent)
Role:
I am working with a leading pharmaceutical company seeking a dedicated and experienced Regulatory Affairs Specialist to join our team in Neuchâtel. In this pivotal role, you will be responsible for managing and maintaining the marketing authorization dossiers for our medicinal products in Switzerland. You will coordinate the preparation, submission, and follow-up of initial marketing authorization applications, as well as lifecycle updates to existing authorizations. If you have a profound understanding of Swiss legislation and are looking for a career in a dynamic environment, we look forward to receiving your application.
Your Key Responsibilities:
* Prepare and compile initial Marketing Authorization Applications (MAAs) for human medicinal products in accordance with Swissmedic requirements.
* Manage the lifecycle of existing MA dossiers, including variations, renewals, and updates in line with Swiss and international regulations.
* Draft, review, and update clinical and non-clinical overviews, summaries, and module components for the Swiss eCTD.
* Coordinate with cross-functional teams, including medical, quality, and pharmacovigilance, to gather, validate, and align data for submission.
* Provide strategic regulatory guidance and ensure regulatory strategy alignment for existing MAs.
* Manage regulatory information systems (e.g., RefData) and internal tracking tools.
* Maintain up-to-date knowledge of relevant regulatory guidelines and Swissmedic procedures.
Your Profile:
* Master’s degree in Life Sciences, Pharmacy, or a related discipline.
* A minimum of 5 years of hands-on experience in regulatory affairs with a focus on Swiss marketing authorization processes.
* Strong knowledge of Swissmedic regulations, eCTD dossier requirements, and ICH guidelines.
* Experience in preparing clinical and non-clinical overviews.
* Proven ability to manage multiple projects, set priorities, and work independently with minimal supervision.
* Excellent communication skills with a collaborative and solution-oriented mindset.
* Fluency in English (C1), French (C1), and German (C1) is essential.
* Knowledge of EU regulatory procedures.
* Familiarity with global marketing authorization processes, such as in the UK, Singapore, Australia, and/or Canada.
What We Offer:
A challenging and varied role in a forward-thinking company with attractive employment conditions and opportunities for professional development.
Interested?
If you wish to take on this exciting challenge, please send us your complete application. We look forward to getting to know you.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
Staffing and Recruiting
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