Regulatory Affairs Associate

Key People

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Job ID :

5447


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Berkshire,Berkshire,


Key Skills :

regulatory affairs, associate, officer, executive, post approval, variations, renewals, registration


Salary :

£30000 - £32000 per annum + bonus and benefits


Date Posted :

12 Dec, 2016



Company Name :

Key People


Location1 :

Berkshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An excellent opportunity has become available for a Regulatory Affairs Associate to join a leading pharma client based in Berkshire. Within this role you will be responsible for the review of technical and administrative documentation for submissions, coordinate and prepare local documents for regulatory submissions.

Responsibilities:

-Assist with registration and post approval activities across the UK, Ireland and Malta
-Develop regulatory plans for straightforward projects
-Validate submission packages to ensure compliance
-Prepare responses to standard questions and comments from regulatory agencies
-Interpret existing regulations and guidance documents within regulatory department and on project teams
-Track status and progress of regulatory documentation and maintain internal tracking and archive systems
-Scrutinize and approve AdProm material according to national requirements
-Proofread and approve English texts for labeling, instruction for use and manuals of Medical Devices

Experience Required:

-Bachelor's degree or country equivalent in pharmacy or related scientific discipline
-1-3 years of regulatory exposure
-Previous Pharma or CRO experience is required

For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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