Senior Specialist - Regulatory Submissions Planner, Global Pharma UK

Recruiter
Just Pharma
Location
Hertfordshire
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
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.

Accountabilities

- 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.

Requirements

- 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