Regulatory Affairs Specialist
Thörishaus, BE - Switzerland
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.
- 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
APPLY FOR THIS JOB
- 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