Job Title: Regulatory Affairs Specialist/Lead
Location: Neuchâtel,Switzerland (On-site mainly)
Employment Type: Full-time
Remuneration: 100,000 - 115,000 CHF
Cpl Life Sciences is working with a growing CRO that partners with biotechnology and pharmaceutical companies globally. The business is seeking an experienced Regulatory Affairs professional to support and manage regulatory submissions and lifecycle maintenance of marketing authorisation dossiers for medicinal products in Switzerland.
The role involves coordinating the preparation, submission, and follow-up of both initial marketing authorisation applications and subsequent lifecycle updates. You will liaise with regulatory authorities (e.g., Swissmedic), suppliers, and strategic partners, ensuring full regulatory compliance across all dossiers.
Key Responsibilities:
* Prepare and compile initial marketing authorisation applications (MAAs) for human medicinal products according to 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 regulatory strategy alignment for existing MA.
* Manage regulatory information systems (e.g. RefData) and internal tracking tools.
* Maintain up-to-date knowledge of relevant regulatory guidelines and Swissmedic procedures.
Requirements:
* Master’s degree in Life Sciences, Pharmacy, or a related discipline.
* Minimum of 5 years of hands-on experience in regulatory affairs with a focus on Swiss marketing authorisation processes.
* Strong knowledge of Swissmedic regulations, eCTD dossier requirements, and ICH guidelines.
* Experience 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.
* Knowledge with EU regulatory procedures.
* Familiarity with global marketing authorization processes such as in the UK, Singapore, Australia, and/or Canada.
For more information, please reach out to me at lucy.kirkaldy@cpl.com
The role is based on site in Neuchâtel,Switzerland, and will require the right person to be based on site.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Science, Quality Assurance, and Strategy/Planning
* Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Research Services
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