Regulatory Affairs Specialist

Department
Regulatory Affairs

Location
Thörishaus, BE - Switzerland

Summary Description
PaxVax is looking to recruit an experienced professional into the role of Regulatory Affairs Specialist.

Purpose of the role

  • Global RA operational function including the compilation, submission and archiving of all variations.
  • Implementation of RA processes that are scalable, including eCTD submissions.

Main accountabilities

  • Responsible for designated regulatory projects and compliance with respective deadlines
  • Submission of variations and maintaining existing marketing authorizations
  • Compiling and updating regulatory dossiers according to international guidelines (EU, FDA, ICH)
  • Interaction with Regulatory Affairs Authorities and distribution partners according to timelines
  • Responsible for the good quality and conformity to regulatory requirements of the submissions
  • Supports local Regulatory Affairs Managers in their RA projects and interfacing with other departments on a local and international level
  • Administration of regulatory documentation and ensuring the traceability of regulatory history (filing, archiving, database etc.)
  • Maintenance of regulatory printing materials

Requirements:

  • The successful candidate will bring a University degree in life science.
  • At least 2-3 years in a professional Regulatory Affairs role
  • Attention to detail, and ability to manage operational interactions with CA’s and vendors
  • Experienced in working with Health Authorities and managing vendors
  • Fluency in English and German, any other language is advantageous
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