The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides
In order to continue our organic growth, we are constantly looking for talent.
Specialist Regulatory Affairs (f/m)
Your responsibilities We look for an excellent communicator with a business mindset You will cooperate closely with internal stakeholders and customers, deliver the regulatory position in development project teams, develop regulatory strategies for our APIs, and actively coordinate project-related work within the RA department. You will be solely responsible for various development projects, sharing relevant project information with your team and thoroughly documenting the regulatory history of the projects.
Your tasks For dedicated projects, you will be responsible for:
Promoting RA Services to support Bachem's NCE business
Representing RA in developmental project teams
Coordinating project-related RA-activities
Delivering the regulatory position regarding CMC development topics
Developing and presenting regulatory strategies
Negotiating with stakeholders
Proper information exchange within the team
Solid understanding of and practical experience in Drug Regulatory Affairs
Master or PhD in chemistry or pharmacy or an equivalent qualification
Fluent and persuasive communicator in English and German
Ideally, experience in CMC development and in project management within the pharmaceutical industry
We offer an interesting position as part of a small, motivated team in a dynamic field of work. In this position, you have the opportunity to deal with complex and diversified tasks and to influence the strategic decisions for the development of the respective API.
Interested? Please submit your application with full supporting documents (motivation letter, CV, testimonials, diplomas) via recruiting tool to Fabienne Carabelli (HR Business Partner)