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Job Details

Regulatory Affairs Manager - Promotional Material and Regulatory Excellence

Company: TEC Group International
Location: London
Reference: kjhnbvc
Closing Date: 13 Mar 17
Type: Full Time
Salary (£): 40,000 - 60,000
Benefits:

Job Summary:

For more information on this job or others please get in contact with our Senior Consultant Sam Murphy on 0208 544 3423 / 07971 477 589 sam.murphy@tecgroup.net

Requirements:

Your responsibilities:

Promotional Material Review Process Owner:

To manage the Promotional Material process and perform related audits thereof.

To act as key contact for the Zinc database

To develop, mentor and run training sessions on the promotional material review process.

Promotional Material Reviewer:

Undertake the review of promotional materials in the capacity of Regulatory Affairs reviewer in compliance with the ABPI code and EU regulation.

Submission Management:

Act as a backup and appropriate submission support to Regulatory Affairs Associates including?support regulatory submissions, approvals and reconciliation of Regulatory changes through to implementation. Status of dossier compliance to be assured at all times.? Liaising with Merck Group Companies, associate companies, licensors and business partners to obtain the necessary information to compile successful submissions to the Regulatory Authorities. Supporting the Regulatory Affairs team for all aspects of artwork requests and approvals.

Who you are:

Fully conversant with Zinc software or similar application is strongly desirable.  Ability to lead the Medical, Legal and Regulatory review process including training new starters, embedding the process across the business, identifying training needs, identifying process improvement and regularly auditing the process.

A Degree or Doctorate in health-related science, life science, Pharmacy.? Previous experience in promotional material review desirable and in Regulatory Affairs is preferred but it is not essential.?If you do not have experience in Regulatory Affairs you will have an interest to develop in this area and undertake regulatory tasks and act as a back-up for the Regulatory team.   

Excellent organisational, verbal, written and communication skills and the ability to work under pressure to tight deadlines.?Good knowledge of clinical data and clinical studies to be able to understand relevance of medical publication.

Apply for this job: Regulatory Affairs Manager - Promotional Material and Regulatory Excellence

Contact Information:

Address:  Head Office
Dowgate Hill House, 14-16 Dowgate Hill, London
EC4R 2SU
England
Tel:  +44 (0) 208 544 3400
Website:  Visit Our Web Site

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