Regulatory Affairs Associate
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Hobson Prior are currently working with one of the world's largest biotech organisations who are looking for a Regulatory Affairs Associate to join them on a contract basis in either Cambridge or Uxbridge.
- Maintenance of regulatory tracking systems: Data entry, administration and reporting from regulatory registration tracking system; maintenance of product history logs.
- System administration: administration of document management systems; maintenance of team Sharepoint sites and associated documentation.
- Information requests: fill internal requests for information and documentation.
- Regulatory archive: submission archival of regulatory dossiers, agency correspondence and records of contact to regulatory archive; upload to document management system, maintenance of product history documents; regulatory information data entry and document linking.
- Quality control: regulatory information data entries and links; regulatory archive locations and file naming.
- Metrics generation: liaison with internal customers to determine key performance and compliance indicators; liaise with reporting groups for data system outputs.
- External partners and vendors: external partner document exchange, support.
- Any other assigned duties.
- Ability to work in a team
- Attention to detail
- Relationship building
- Good written and verbal communication skills
- Time and project management skills
- Use of document management systems and databases.
- Familiarity with Global Clinical Trial Applications, Marketing Authorizations.
- General understanding of industry practice and standards.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.