CMC Pre-approval Regulatory Affairs Manager - Geneva
Meyrin, Geneva, CH
We are currently recruiting a CMC Pre-Approval Regulatory Affairs Manager to join our team at OM Pharma’s headquarters and biotech production site in Geneva.Reporting to the CMC Regulatory Affairs Team Lead, you will play a key role in shaping regulatory strategies for biological development programs, ensuring the compliance of our products for successful initial registrations.
Your main responsibilities will include:
- Designing and implementing regulatory CMC strategies for investigational and registration dossiers, in collaboration with cross-functional teams (e.g. quality, clinical, other regulatory sub-functions)
- Authoring and coordinating the preparation of CMC regulatory submissions (EU/US) for clinical phases and initial marketing applications, in line with current regulations and internal procedures
- Managing responses to Health Authority questions and supporting agency interactions
- Providing regulatory input on change controls related to CMC topics in development, including the submission of relevant amendments
- Acting as the CMC regulatory representative in cross-functional project teams, identifying regulatory risks and proposing mitigation strategies
- Fostering a culture of collaboration and regulatory excellence by sharing expertise and challenging the status quo to drive innovation and quality
To carry out this mission, we are looking for a person with the following profile:
- University degree (MSc or PhD) in Biological or Biotechnological Sciences or equivalent
- Minimum of 5 years' experience in CMC regulatory affairs (pre-approval phase) or in biologics development with strong regulatory involvement
- Proven experience in preparing regulatory dossiers for EU and/or US submissions
- Solid knowledge of biological drug substance and drug product development; prior exposure to products administered via nasal route, fermentation-based products, combination products, or Class I medical devices is a plus
- Fluent in English (oral and written); good command of French is an asset
You are a solution-oriented and adaptable professional who thrives in dynamic environments. Your working style is proactive, rigorous, and collaborative, and you are skilled at managing tight timelines without compromising quality. Your communication and negotiation abilities allow you to work efficiently across diverse internal and external stakeholders.
Join a collaborative and entrepreneurial team where your expertise will help shape the future of our product portfolio. Apply now and make a difference with OM Pharma!
