Senior Regulatory/ Regulatory Affairs Officer
Hours: 8:00 - 16:30 Monday to Friday, ONSITE.
Salary: Upto £30,000
Russell Taylor is working exclusively with a well-known 'generics' - Pharmaceutical manufacturer based in Widnes and part of a wider/ national consortium. They are looking to appoint a Senior RA Officer or someone who is wanting to step up into a more senior RA role from being an RA Assistant.
- To maintain marketing authorisation compliance via life cycle management of existing licences and maintaining awareness of new regulatory legislations
- To submit MAA, Piggy-back and Site Transfer variations to support the NPD pipeline
- Author and review Regulatory SOP's
- Submit sunset clause applications, change of ownership applications, and licence renewals as required
- Manage artworks using the ProcEdge system
- Complete and manage closure of Regulatory change controls
- Maintain Technical Summaries for all licenced products
- Liaise with external regulatory agencies to facilitate variation approvals
- Build strong relationships with customers and members of other departments
- Ensure Safety variations are submitted within PV timelines
- Ensure Regulatory approvals are communicated to the relevant departments within specified timelines
- Previous RA experience in an GMP /MHRA - Pharmaceutical setting is essential for this role.
- Experience/d in artwork approval/s and submissions.
- Able to demonstrate strong written and verbal English.