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Specialist Regulatory Affairs (f/m)

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.

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

 

Your profile

  • 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
  • Strategic, solution-oriented mindset
  • Convincing attitude 
  • Understanding for concepts and principles
  • Committed, creative, well-structured work-attitude
  • Ideally, experience in CMC development and in project management within the pharmaceutical industry 

 

We offer

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)