Senior Regulatory Affairs

Employer
Michael Page
Location
London, England
Salary
£50000 - £51000 per annum
Closing date
17 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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An autonomous Regulatory Affairs role - mentoring a small team.

Client Details

An award winning, International, fast growth pharmaceutical business.

Description

The key duties include:

Assist in the preparation and review of dossiers for MA applications (DCP, MR or national) and ensure timely submission of applications.

Assist in the preparation and review of dossiers for MA variation applications, MA renewals and other regulatory submissions (DCP, MR or national) and ensure timely submission of applications

Assist in the preparation and review of responses to requests for further information from regulatory authorities

Prepare or review of national submission packages after the close of procedures

Liaise with regulatory authorities when required

Maintaining the product life cycle once the licence is approved.

Responsible for the product approval package review and maintenance.

Review of product information before product launch.

Liaising with internal and external contacts to ensure that dossiers are prepared following the current best practice standards.

To support the Regulatory Manager with SOPs, Change controls and review of internal processes.

Profile

The successful candidate will be a genuine self-starter with previous experience of Regulatory Affairs.

Experience of EU registration via DCP/MRP is essential, as is the ability to mentor more junior members of a small team.

Job Offer

A fantastic opportunity to join a growing business at a key phase of their development.

The opportunity to work with a Senior Director but to also manage your own work.

An opportunity to mentor a small team.

A competitive salary

About us The original PageGroup brand, Michael Page is comprised of 25 disciplines – each providing a service to a specialist area of the market. We recruit permanent, temporary, contract and interim opportunities, typically from second/third job levels upward. Businesses we work with range from SMEs to global blue-chip organisations.

LinkedIn award

 

The UK

Our business started life in the UK in 1976, as a two-man operation above a laundrette. Nearly four decades later we have more than 7000 employees and a global office network, while growing our UK market coverage too.

With offices from Aberdeen to Bristol and Cardiff to Cambridge, and more than 25 specialist businesses we have the track record to handle your recruitment requirements or job search. We combine our local knowledge and global expertise to provide a specialised service to both employers and candidates.

Contact Us
  • Michael Page International Ltd,3rd Floor
  • The Switch Building
  • Slough
  • SL1 1QP
  • United Kingdom
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