Regulatory Affairs Specialist

Department
Regulatory Affairs

Location
Thörishaus, BE

Summary Description
PaxVax is a specialty vaccines company, which belongs since October 2018 to Emergent BioSolutions focused on the travel and endemic disease markets with a mission to develop and commercialize innovative vaccines against infectious diseases in a socially responsible manner. The Company has several sites in the US and in Europe.

At PaxVax Berna, the Swiss company there are - beside manufacturing activities – professionals in Quality Assurance and – Control, Supply Chain and Regulatory affairs working. The Swiss company, with its more than 100 professionals, is heading to the next period of growth.

We are 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 e 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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