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(Senior) Specialist/Manager RA 100% (m/w/d)

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.

To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our Regulatory Affairs (RA) Team, we are looking for a Regulatory Affairs Senior Specialist / Manager (temporary for 2 years, with prospect of permanent position, 100%, f/m/d).

You will take full responsibility for your assigned projects/tasks while benefiting from working within a highly motivated and innovative team.

 

Your tasks

 

  • Key role within the implementation process of a new Regulatory Information Management System and coaching of RA colleagues.
  • Identification of areas for improvement within the RA unit and RA-stakeholder interfaces. Initiation of appropriate initiatives driving innovation, modernization, and enhancement of processes.
  • Hands-on writing and review of regulatory documents of different backgrounds in accordance with applicable regulatory rules and guidelines.
  • Support of RA colleagues with projects, gradually develop into representation of RA in customer projects.
  • Coordination of responses to RA-related customer requests.
  • Coordination of responses to authority requests in close collaboration with our customers.
  • Delivery of regulatory advice to internal and external stakeholders.
  • Review of documents and assessment of GMP changes from RA perspective.
  • Management of internal and external stakeholders to reach regulatory objectives while demonstrating high degree of integrity, reliability, resilience, tenacity, openness and collaborative spirit.

 

Your profile

 

  • University degree Master and/or PhD with focus on Natural Sciences (Chemistry, Pharmacy, or similar field).
  • At least 2 years of professional experience in an RA function.
  • Experience with Regulatory Information Management Systems (preferably Veeva).
  • Experience with migration and/or implementation of IT projects is a plus.
  • Strong communication and collaboration skills and strategic mindset.
  • Flair for presenting scientific facts.
  • Committed and well-structured work-attitude.

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

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