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Job Details

Senior Regulatory Officer, CMC / Essex

Company: Turner Regulatory
Reference: 10091-1
Closing Date: 30 Nov 17
Type: Permanent
Salary (£): 40,000 - 60,000

Job Summary:

Senior Regulatory Officer CMC; Modules 3 and 2.3; good all round Regulatory skills; EU Procedures; Variations and Renewals etc. EU, UK and some International.


Excellent opportunity for a Regulatory Officer/Senior Officer CMC!! Essex location.

This highly successful Pharma Company, seeks a Senior Regulatory Officer CMC for their Team in Essex. Branded and Generic Product mix. Good technical knowledge of drug development and manufacturing processes. You will represent Regulatory CMC in the New Product Development Project Team and ensure CMC Regulatory Strategy is implemented for development projects and marketed products.

If you are a top-end Regulatory Officer CMC, or already a Senior Regulatory Officer CMC possessing with 3-5+ years experience in Regulatory Affairs, this is the role for you. Operating across regions, you will understand Development, Registrations and Post marketing/maintenance; you will possess good experience in the following processes: IMPD's; CTD/Dossiers for MAA's (particularly focusing on writing, compiling and reviewing Modules 2.3 and 3); 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.

Reporting to the Regulatory Affairs Compliance Manager, 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 assigned regions. 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 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 Regulatory Affairs CMC experience. Working knowledge of Pharma or Generic Products.

A generous salary package in offered, including bonus and benefits. Essex location.

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, CMC / Essex

Contact Information:

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

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