Regulatory Affairs Specialist 897366 MSI

For our pharmaceutical clients in Switzerland we are constantly looking to connect with experienced professionals in several areas, including pre-clinical development, clinical research, medical affairs, regulatory affairs, etc.

 

Regulatory Affairs is one such area that we always like to pipeline because of the high demand at the same time niche domain that it is. Therefore if you wish to grow and looking for your next challenge, let us connect for an exciting CMC Regulatory Affair Specialist role.

Regulatory Affair Specialist ID 897366 MSI

For our pharmaceutical clients in Switzerland we are constantly looking to connect with experienced professionals in several areas, including pre-clinical development, clinical research, medical affairs, regulatory affairs, etc.

 

Regulatory Affairs is one such area that we always like to pipeline because of the high demand at the same time niche domain that it is. Therefore if you wish to grow and looking for your next challenge, let us connect for an exciting CMC Regulatory Affair Specialist role.

 

The ideal candidate should have min +4 years of previous experience in Regulatory Affairs in the Pharmaceutical industry.

 

Purpose: As a CMC Regulatory Affairs Specialist you will cooperate closely with internal stakeholders and customers, deliver the regulatory position in development project teams, develop regulatory strategies for company 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.

 

Main Responsibilities:

  • Preparation and submission of regulatory documentation including correspondence with health authorities and customers

  • Development of regulatory pre- and post-approval strategies

  • Regulatory assessment of changes to GMP documents

  • RA representation in project teams

   Qualifications and Experience:

  • Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
  • Master or PhD in chemistry or pharmacy or an equivalent qualification
  • Fluent in German and English
  • Flair for presenting scientific facts
  • Committed, creative, solution-oriented, well-structured work-attitude honoring timelines
  • Strategic mindset
  • Convincing attitude and persuasive communication
  • Understanding for concepts and principles
  • Ideally, experience in Drug Regulatory Affairs

  • CTC Clinical Trial Consulting AG
    Mr CTC Resourcing Solutions
    Münchensteinerstrasse 41
    4052 Basel
    +41 61 695 88 66





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