Regulatory Affairs Manager (remote)

Hiring By - Biostaffic


United Kingdom

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
Proclinical are recruiting for a Regulatory Affairs Manager to join a pharmaceutical organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.
Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.
  • Contribute to RA team meetings, product team meetings and divisional meetings.
  • Attain a comprehension of the regulatory setting leveraging internal expertise and external regulatory intelligence.
  • Aid post-marketing actions for preparing regulatory proposals which might involve variations, PSURs/RMPs, replies to questions and renewals.
  • You will use and update regulatory information systems for planning, preparing, tracking and storing proposals to regulatory agencies.
  • Other duties may be assigned.
Key Skills And Requirements
  • Educated to a degree level in a life science field.
  • Demonstrable experience in regulatory affairs.
  • Comprehension of regulatory needs for the EU centralised process and IC/GPS region.
  • Familiarity assisting post-licensing management of variations, renewals, responses to questions, Follow-up Measures, PSURs etc. for the IC/GPS region.
  • Acquaintance working with document management systems such as RDMS and GPLM systems.
  • Capable of enabling/impacting and influencing efficient engagements and conversations.
  • Ability to engage to collate information and efficiently drive projects through to accomplishment to tight timelines.
  • A background and comprehension in science.
  • Communication skills both verbally and in writing.
  • Fluency in the English language.
  • An organised individual with the ability to work on various projects concurrently to meet tight timelines.
  • Works well in a team with analytical and assessment capabilities.
  • Works well under minimal supervision.
  • Able to resolve issues with the capacity to think tactically.
  • A high attention to detail.
  • Comprehension and relation to both external and internal customers.
  • Business aware with the ability to present self in a professional manner.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • United Kingdom


  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 18, 2024
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