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

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 and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.

We are looking for an Senior Manager RA (permanent position, 100%, f/m/d) with excellent communication skills and a business mindset who provides value-added input to internal stakeholders and clients.
You will take full responsibility for your 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 multi-country, -customer and -product environment in accordance with applicable regulatory rules and guidelines.
  • Representation of Regulatory Affairs in internal and external (e.g., customers and authorities) stakeholder discussions and negotiations during the whole product lifecycle.
  • Design and ownership of regulatory strategies for development, rollout and life-cycle stage projects.
  • Delivery of regulatory advice to internal and external stakeholders and of regulatory assessments within the framework of change control.
  • Steering of site-overarching initiatives for improvement and innovation while proactively anticipating challenging situations.
  • Management of internal and external stakeholders to reach regulatory objectives while demonstrating high degree of integrity, reliability, resilience, tenacity, openness and collaborative spirit.
  • Coaching RA members, as well as actively contributing to the knowledge -building and transfer within the RA Unit.

 

Your profile

  • University degree Master and/or PhD with focus on natural sciences (Chemistry, Pharmacy, or similar field).
  • Further training and certification in the relevant discipline.
  • At least 5 years of professional experience in regulatory affairs function.
  • Solid experience with the preparation, including technical writing, of Chemistry, Manufacturing and Control sections.
  • Solid experience with the registration requirements for Active Pharmaceutical Ingredients.
  • Solid experience of the regulatory requirements, dossier submission and life cycle management for Active Pharmaceutical Ingredients for global markets.
  • Solid experience in communication with customers and regulatory agencies.
  • Fluent and persuasive in French (C1) and English (C1) – German as a plus.
  • Experience in supervising complex projects and establishing regulatory strategies.

 

We offer

We offer an exciting and challenging position in a dynamic environment that guarantees you diversity. You will be joining a team of qualified specialists, and you will be able to develop yourself professionally. In addition, we offer you the opportunity to work in an innovative environment and in a motivated team. You can expect modern terms of employment and attractive fringe benefits.

 

Interested

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

Please note: unsolicited resumes from recruitment agencies will not be considered.

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