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Job Details

Senior Regulatory Officer / EU

Company: Turner Regulatory
Location: Buckinghamshire
Reference: 10077-33
Closing Date: 05 Feb 18
Type: Permanent
Salary (£): 40,000 - 60,000
Benefits: Bonus and good benefits

Job Summary:

Senior Regulatory Officer. Buckinghamshire/Berkshire. European Submissions.


Excellent opportunity for a Regulatory Officer specialising in European Markets!!

This highly successful Pharma Company, seeks a Regulatory Officer for their European Team. Branded and Generic Product mix. You will interface with Regulatory Agencies and proactively to respond to RFI's. You will implement assigned Regulatory Strategy for this region.

If you are a top-end Regulatory Officer, or already a Senior Regulatory Officer possessing 3-5 years in European Regulatory Affairs, this is the role for you. With a specific focus on European activity, you will understand Registrations and Post marketing/maintenance; ideally, you will possess good experience in the following processes: CTA's; CTD/Dossiers for MAA's (focus on Modules 1, 2 and 3, but also reviewing all Modules 1 to 5); European Procedures: experience in National Submissions/MRP, DCP and ideally Centralised Procedure; Post marketing/Life-cycle maintenance: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. PSUR's. Sunset Clauses.

Reporting to the Deputy Head of Regulatory Affairs, you will focus on numerous Therapeutic Areas: Specials, Addictions, Critical Care, Ophthalmics and Hospital Steriles. This role will focus on both Branded and Generic Products. You will ensure that a company's products comply with the regulations within the assigned region. The environment is diverse and you will operate cross functional teams and subject matter experts/corporate partners. You will have the ability to work independently and proactively, discover solutions to challenges by obtaining data from multiple and diverse resources as required to support EU Regulatory Submissions.

You will require only minimal supervision for day-to-day activities, product support and project oversight/execution. You will have excellent prioritisation and time-management skills. 3-5 years solid EU Regulatory Affairs experience. Working knowledge of Pharma or Generic Products. A generous salary package in offered, including bonus and benefits.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on 0203 695 9477/07447 977 330 or, or by clicking Apply Now.

Apply for this job: Senior Regulatory Officer / EU

Contact Information:

Address:  Head Office
71-75 Shelton Street
Covent Garden
Tel:  0203 695 9477
Website:  Visit Our Web Site

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