10 "senior regulatory affairs specialist" Jobs

Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary. Ensure teams understand the potential opportunities and...

To drive process standardization, excellence and change specifically related to Submission Management, whether driven by improvement or change in operating model; capturing and analysing areas...

The successful Regulatory Officer will support on a variety of projects, working closely with the analytical team to devise compliance plans to suit customer needs...

This is a multi-faceted position responsible for the coordination of all Renewals, Tenders, RTQs and Site Registrations submissions. This role will be responsible for ensuring...

Gain regulatory authority approval for new clinical trials and amendments to such trials undertaken in the UK and Malta as appropriate. Gain marketing authorisations for...

Perform post-publishing tasks including organization of submission printing where applicable, to ensure timely despatch and archival of regulatory submissions, and effective maintenance of supporting documentation....

To prepare high quality CMC detailed regulatory documents using varied information sources. liaising closely with other company personnel to ensure accuracy of such records. Role...

Planning, preparation and submission of MA applications, post approval, variations, renewals, post marketing commitment submissions and other ad hoc activities in support of maintaining MAs...

To ensure that Investigator Brochures are created, revised and submitted in compliance with governing SOPs and ICH requirements. The IB Manager compiles the Investigator Brochure...

The Principal Regulatory Affairs Executive is responsible for preparing high quality documentation for all regulatory submissions, primarily CMC variations, will also be responsible for planning...