Regulatory Affairs Manager

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