Senior Manager Regulatory Affairs (f/m/d) 100%

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Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise, Bachem provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide. The company offers a comprehensive range of services and operates internationally with headquarters in Switzerland, along with locations in Europe, the US, and Asia. Bachem is listed on the SIX Swiss Exchange. For further information, see.

We are looking for a Senior Manager RA (permanent position, 100%, f/m/d) with excellent communication skills and a business mindset. The successful candidate will provide value-added input to internal stakeholders and clients, taking full responsibility for assigned projects/tasks while benefiting from a strong collaboration within our small and motivated team.

Your tasks

• Within our innovative RA team, you will be responsible for:
• Hands-on regulatory dossier writing and regulatory maintenance (e.g., regulatory dossiers, import licenses, and site registrations) in a multi-country, -customer, and -product environment, in accordance with applicable regulatory rules and guidelines.
• Representation of Regulatory Affairs in internal and external stakeholder discussions and negotiations during the product lifecycle.
• Design and ownership of regulatory strategies for development, rollout, and lifecycle stage projects.
• Delivery of regulatory advice to internal and external stakeholders and regulatory assessments within change control frameworks.
• Steering site-overarching initiatives for improvement and innovation, proactively anticipating challenging situations.
• Managing internal and external stakeholders to achieve regulatory objectives, demonstrating integrity, reliability, resilience, tenacity, openness, and a collaborative spirit.
• Coaching RA team members and actively contributing to knowledge building and transfer within the RA Unit.

Your profile

• University degree (Master and/or PhD) in natural sciences (Chemistry, Pharmacy, or similar field).
• Further training and certification in relevant disciplines.
• At least 5 years of professional experience in regulatory affairs.
• Solid experience in preparing (including technical writing) Chemistry, Manufacturing, and Control sections.
• Experience with registration requirements for Active Pharmaceutical Ingredients.
• Experience with regulatory requirements, dossier submission, and lifecycle management for Active Pharmaceutical Ingredients in global markets.
• Strong communication skills with customers and regulatory agencies.
• Fluency in French (C1) and English (C1); German is a plus.
• Experience supervising complex projects and establishing regulatory strategies.

We offer an exciting and challenging position in a dynamic environment that guarantees diversity. Join a team of qualified specialists and develop professionally. We provide an innovative work environment, motivated team, modern employment terms, and attractive fringe benefits.

Please submit your application with full supporting documents (motivation letter, CV, testimonials, diplomas) online via our Recruiting-Tool.

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