Regulatory Affairs Officer

Company
Servier
Location
Stoke Poges, Slough
Salary
Competitive
Posted
28 Apr 2021
Closes
28 May 2021
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Servier UK are looking for a Regulatory Affairs Officer

6 Months Fixed Term Contract Position (Starting early June)

UK-based (Stoke Poges) with the possibility of remote working

Full-time preferred, but part-time considered for the right candidate

 

Main responsibilities

To assist the Regulatory Affairs Manager in providing a proactive and effective Regulatory Affairs service in order to support the timely development and marketing of the Company’s medical products while ensuring the continuing enhancement of both the Company’s ethical image and regulatory compliance.

 

MHRA – UK Competent Authority

  • To submit, vary, renew and maintain marketing authorisations and wholesale dealer’s authorisation to keep them current, in close consultation with Worldwide Regulatory Affairs, to include post Brexit activities to meet national requirements.
  • To obtain regulatory approval for packaging component changes required by MHRA or Servier and to follow up their implementation in a timely manner to ensure regulatory compliance.

 

Regulatory and Packaging Compliance

  • To create, review and update SOPs for the regulatory function to reflect best working practice and consistency with Group procedures.
  • To review samples of incoming batches of product to ensure packaging compliance.
  • To communicate changes to Servier Product Information in compliance with the prevailing guidance/legislation.

 

Pharmaceutical Responsibility Delegate

  • With appropriate training, to act as delegate in the absence of the Regulatory Affairs Manager for Product Complaints and Product/Batch Recall.

 

Environmental awareness

  • Awareness of current UK and EU legislation and its impact for Servier in the UK, particularly in relation to Brexit.

 

Requirements for the role include:

Minimum 2 years UK regulatory experience as Regulatory Officer/Specialist

Some knowledge of Publishing would be an asset

Excellent communication and interpersonal skills.

Able to work autonomously and as part of a team.

Good organisational skills.

Ability to drive efficiencies and change.

Flexible.

 

To report a side effect with one of our products, please visit

https://www.servier.co.uk/report-a-side-effect/

Reporting forms and information can also be found at

www.mhra.gov.uk/yellowcard

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