Regulatory Affairs Systems and Operations Manager
Location - Hertfordshire (Remote) 1 day in the office per month
Salary Up to 75,000
Job reference - JO-2205-493856
Were supporting a Systems and Operations Manager opportunity working for a rare disease biotech based in Hertfordshire. The business works across immunology, critical care, and coagulation disorders and looking for a RIMs specialist to maintain the smooth running of VEEVA Vault systems.
In this role, you will be responsible for the planning/creating/dispatching of high-quality CTD and eCTD dossiers as well as proposals for appropriate software solutions and systems to support business processes.
- Maintenance of Veeva Vault systems across the business and supporting the implementation of dossiers
- Ensuring compliance of paper, NeeS and electronic dossiers with health authority requirements worldwide with the aim to be fully electronic wherever and whenever possible.
- Identifying system requirements as well as defining and delivering well-suited solutions that meet the needs of authors regarding the preparation and management of source documents, the planning and tracking of submissions, the viewing and archiving of dossiers
- 1 direct report that may ask for guidance on publishing activities.
- Bachelors degree or higher in Life Sciences.
- Previous experience working with Veeva Vault Systems.
- Previous publishing experience would be desirable and experience across global markets.
- Good knowledge of regulatory procedures IND, CTA, PSUR, NDA, EU Centralised.
The role is an excellent opportunity to work within an innovative environment and be the lead in implementing Veeva Systems. This opportunity allows for great career progression opportunities as well as the opportunity to work remotely with the occasional meeting in the office-based in Hertfordshire. The role also includes a 10% bonus, private health insurance, pension, life insurance, and 25 days of holiday.
If you are interested in this role or would like more details please email your CV to firstname.lastname@example.org
- Agency: Cpl Life Sciences
- Reference: JO-2205-493856
Website: Cpl Life Sciences
- Posted: 6th September 2022
- Expires: 4th October 2022