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Regulatory Affairs Manager
- Contract
- Project Manager
- United Kingdom
This vacancy has now expired. Please see similar roles below...
Proclinical are recruiting for a Regulatory Affairs Manager to join a pharmaceutical organisation. This role is on a contract basis and is located in either Cambridge or Uxbridge.
Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.
Responsibilities:
- Assist in post-marketing actions for preparing regulatory proposals which might involve variations, PSURs/RMPs, responses to questions and renewals.
- Responsible for preparing and upholding labelling to assist MAAs and any other post-licensing actions.
- Guarantee any updates to the product company core data sheet are executed in the impacted local market in a timely manner.
- Contribute to RA team meetings, product team meetings and divisional meetings.
- You will use and update regulatory information systems for planning, preparing, tracking an storing proposals to regulatory agencies.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a life science degree level.
- Demonstrable work experience in regulatory affairs.
- Comprehension of regulatory needs for the EU centralised process and IC/GPS region.
- Familiarity with assisting in post-licensing management of variations, renewals, replies to questions, follow-up measures, PSURs etc., for the IC/GPS region.
- Prior involvement working with document management systems such as RDMS and GPLM system.
- Capable of enabling/impacting and influencing efficient engagements and conversations.
- Ability to engage to information collate and drive projects through to accomplishment to tight timelines.
- A scientific background and solid comprehension.
- Communication skills both verbally and in writing.
- Fluency in the English language.
- An organised individual with the ability to work on various tasks simultaneously.
- Works well in team.
- Capable of working well while under minimal supervision.
- Able to think strategically as well as resolve issues.
- A high attention to detail.
- Comprehension of both external and internal customers.
- Business awareness with the capacity to present self in a professional manner.
If you are having difficulty in applying or if you have any questions, please contact Dracen Black at d.black@proclinical.com.
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.
#Regulatory
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