Regulatory Affairs Manager (UK & Ireland)

Cambridge, England
Sep 30, 2016
Oct 28, 2016
Emilie francis
Result Type
Position Type
Full Time

Regulatory Affairs Manager - Uk & Ireland - 2 Year FTC

A dynamic and forward-thinking Pharma company based in Cambridge has an opening for an experienced Regulatory Affairs Manager to be responsible for the UK and Ireland.

You will be joining an established and talented team, where your main responsibilities will be:

- Advising the wider Regulatory team on any issues pertaining to the UK and Irish market.
-Preparing, submitting and performing maintenance activities relating to MAAs
-Liaising with third party companies where UK and IE are the local distributor
-Liaising with the RAST leaders and CMC department where appropriate
-Respond to questions from the Regulatory Authorities
-Conducting MA maintenance in the form of renewals/variations
-Undertaking a high level of professional responsibility, making decisions and solving problems
The ideal candidate would posess:
-3 years+ management experience in a Regulatory capacity
-Excellent communicated and comfortable liaising with all levels of seniority
-BSc, HND, or equivalent industry experience
-High accuracy and attention to detail
-Strong ability to influence internal and external bodies
-Able to work unsupervised and to strict deadlines
-Strong motivational spirit and enthusiasm

This innovative Pharma has a reputation for instilling an entrepreneurial spirit into it's employees by encouraging open communication between all levels, and offers continued training for additional career development purposes. They offer a competitive salary, and flexible benefits package which can be used on pension, additional holidays and more.

To hear more details, or to submit an application for this opportunity please forward a copy of your up-to-date CV to, or call on 0121 616 3477.

Regulatory Affairs, UK, Ireland, IE, HPRA, Manager, Post-Marketing, Pharmaceutical, Cambridge, Stevenage, beford, Hertfordshire, St Albans, Luton, Variations, Renewals, entrepreneurial, Licence Maintenance, Irish authorities, MHRA, Labelling, Artwork, SMPC

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