Senior Specialist - Regulatory Submissions Planner, Global Pharma UK

Just Pharma
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
JustPharma are now searching on behalf of a globally recognised pharmaceutical company for a regulatory professional with a demonstrated understanding of EMEA guidelines to take up a Senior Specialist role within their Regulatory Operations department in South Herts, UK.

My client, a world leader in the development of new drug therapies, are continuing their expansion with this position which will be office-based and working on a full-time, permanent basis. Highly competitive salaries are on offer along with a comprehensive benefits package, and this an excellent opportunity for an experienced Submissions Planner to join a dynamic and expanding organisation.


- Planning, coordinating and reviewing regulatory submissions with release to country operations teams/submissions to Health Authorities.
- Development/implementation of the regulatory submission plan for the assigned projects.
- Work closely with the US counterpart to ensure the meeting of milestones on the assigned projects.
- Close working with Global Publishing Teams to ensure timely assembly, publishing and archiving of assigned projects.
- Maintain and update the regulatory systems and databases.
- Continuous improvement initiatives; improve the efficiency of the regulatory submissions process.


- BSc in Life Sciences or related discipline.
- Experienced within a regulatory operations area (regulatory affairs experience preferred).
- Project Management capabilities and understanding of EMEA regulatory guidelines.

Regs, Operations, Affairs, Ectd, Clinical Technical Document, Modules, MHRA, EU, European, CIS, Global, International, Planning