Manager RAC (Regulatory Affairs and CMC (m/w/d)
full-time
19.05.25
Manager RAC (Regulatory Affairs and CMC (m/w/d)
As part of our growth strategy and product portfolio, we are offering a new challenge as Manager RAC (Regulatory Affairs & CMC) at our site in Bubendorf, Switzerland. You will be a member of the local regulatory affairs and CMC team dedicated to the Drug Substance and ADCs/Bioconjugates Business Unit, supporting customer activities focused on Chemistry Manufacturing and Controls (CMC) for Biologics and Chemistry projects. This dynamic, hands-on role involves collaborating with other departments to coordinate regulatory activities from clinical development to market launch and lifecycle management. You will provide regulatory support and advice internally and to external customer projects.
Your responsibilities:
1. Authoring, reviewing, and maintaining registration documents (DMFs, Drug Substance CMC Quality Modules/sections for INDs, IMPDs, NDAs, BLAs, and MAAs) in compliance with regulatory requirements and international guidelines.
2. Assisting with the submission of post-approval change documentation and conducting regulatory assessments related to change management (change controls, deviations).
3. Providing CMC regulatory support throughout the entire process from pre-clinical to clinical phases and market launch, including interactions with customers and project teams.
4. Performing regulatory reviews of source documents supporting CMC documentation.
5. Leading or conducting project-specific CMC regulatory gap analyses to drive CMC development.
6. Collaborating with health authorities and customers by preparing briefing documents and responding to questions on submitted registration documents.
7. Supporting internal regulatory projects not related to customers.
Your profile:
1. Master's, Engineering, or Ph.D. degree in Biochemistry, Chemistry, Pharmacy, or a related scientific discipline.
2. Strong understanding of regulatory affairs for drug substances, especially CMC development for biologics and/or chemical products.
3. Good knowledge of cGMP regulations and ICH guidelines for small molecules and biologics.
4. Minimum 5 years of experience in the pharmaceutical industry, including at least 2 years in an RA department and prior CMC experience (R&D, Operations, Analytics).
5. Experience in CDMO or customer project environments is advantageous.
6. Team-oriented, proactive, problem-solving mindset, service-oriented, with flexibility to manage multiple tasks.
7. Excellent coordination and communication skills; fluency in English required; basic German knowledge recommended.
8. Reliable, responsible, and trustworthy.
9. Knowledge of eCTD submission software (e.g., Docubridge) is a plus.
We look forward to receiving your application!
CARBOGEN AMCIS is a leading provider in product and process development, including the commercial production of active ingredients for the pharmaceutical and biopharmaceutical industries. We operate across Switzerland (Aarau, Hunzenschwil, Bubendorf, Vionnaz) and internationally in France, the UK, China, and the Netherlands. Our success is driven by the expertise of our employees. Learn more about careers at www.carbogen-amcis.com/careers.
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