Regulatory Affairs Manager (Remote)

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.

Responsibilities:

• 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 p.duvall@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