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Job Details

Regulatory Affairs Manager

Company: Regulatory Professionals
Location: Berkshire/London
Reference: J25241
Closing Date: 09 Apr 17
Type: Full Time
Salary (£): On Application

Job Summary:

Regulatory Affairs Manager: Berkshire/London Permanent Role. Salary: £45,000-£55,000 per annum + benefits package. A proactive Regulatory Affairs Manager is required to join this fast-expanding pharmaceutical company


Regulatory Affairs Manager
Location: Berkshire/London
Permanent Role
Salary: £45,000-£55,000 per annum + benefits package
Reference: J24939
A proactive Regulatory Affairs Manager is required to join this fast-expanding pharmaceutical company, this role will require you to assist in theprocessing of Market Authorisation Applications to UK, Ireland and Global Markets.

Main responsibilities:
* Processing of Market Authorisation Applications
* Maintenance of MAAs (National and MRP)
* Experience in amending and approving artworks
* Reviewing, writing and advising on SmPCs and packaging
* Maintenance of regulatory compliance of the company, carrying out gap analysis and MA review

Required experience:
* Degree in Life Sciences, Pharmaceutical Sciences or equivalent
* Generics background is advantageous
* 4+ years Regulatory experience
* Experience in European procedures - MRP, DCP, CP and NP
* Excellent communication skills
* Ability to manage workload in an organised and timely manner, adhering to tight deadlines

Keywords: Regulatory, Affairs, Senior, Officer, Associate, Executive, Manager, Europe, EU, EMEA, Global, MRP, DCP, CP, NP, MAA, CTA, eCTD, SmPC, Labelling, Labelling, Artwork, Berkshire, West London, London, Hampshire, England, Middlesex

Apply for this job: Regulatory Affairs Manager

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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