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Job Details

Regulatory Affairs Officer

Company: Regulatory Professionals
Location: Berkshire
Reference: J30996
Closing Date: 20 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: DOE + Benefits Package

Job Summary:

Regulatory Professionals are recruiting on behalf of a pharmaceutical manufacturing and marketing company based out of the United Kingdom. Their primary focus is on the European and Australian markets with a view to expand and develop into further markets across the world in the future.

Requirements:

Regulatory Affairs Officer
Location: Berkshire
Salary: DOE + benefits
Ref: J30996

Regulatory Professionals are recruiting on behalf of a pharmaceutical manufacturing and marketing company based out of the United Kingdom. Their primary focus is on the European and Australian markets with a view to expand and develop into further markets across the world in the future. Our client's services include IP licensing, manufacturing and R&D amongst others, provided through their UK facilities or via several global partnerships.

This is a brilliant opportunity for a keen individual to grow their Regulatory experience within a supportive, dynamic environment, where personal and professional development is encouraged and valued.

Responsibilities:
* Prepare and submit applications of reliable quality in a timely manner to MHRA (UK) via National Procedure, including new licence applications, variations, artwork changes, RFIs, and updates.
* Work with QPPV on PSUR submissions, update SmPC and labelling in line with the Company Core Data sheets.
* Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
* Maintain records and documentation in line with the relevant authorities.
* Assist in preparation of procedures for relevant regulatory activities, and in preparation and review of procedures for other areas.

Experience/Skills required:
* A pharmaceutical/Life Sciences degree or equivalent experience.
* 1-2 years of Regulatory Affairs industry involvement
* Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
* Ideally have had exposure to NeeS/eCTD format and electronic submission gateways.
* Knowledge of Generic products and MRP/DCP submissions is desirable.

Alternatively, if you know someone who may be interested, we offer a great referral scheme whereby we will give you £250 in vouchers of your choice if the individual then gets placed in a role with us.

Berkshire, Buckinghamshire, Oxfordshire, Hampshire, Surrey, regulatory affairs, officer, associate, EU, UK, eCTD, MRP, DCP, submissions, labelling, SmPCjo

Apply for this job: Regulatory Affairs Officer

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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