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Senior Regulatory Affairs Specialist

Job description

Job Responsibilities;

  • The Senior Regulatory Affairs Specialist will be responsible for registration document(s) procurement, preparation, coordination submission and archival 
  • You will coordinate legalization and delivery of registration documents following the instructions provided in the request. 
  • The Senior Regulatory Affairs Specialist will maintain tracking and organization of documentation, including uploading in CSD tool or other document repository. 
  • Supports the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed. 
  • Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses. 

 

The next Senior Regulatory Affairs Specialist should have a Bachelor/Master’s degree (Regulatory, Life Sciences, Biotechnology or related discipline) 

You should also have a basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS) 

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