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Job Details

Regulatory Project Manager

Company: Zest Scientific
Location: Nottingham
Reference: 2800
Closing Date: 16 Mar 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Are you a Regulatory Affairs professional from the pharmaceutical or clinical research sectors? Do you have experience of managing regulatory submissions plus working knowledge of GCP or GMP? Zest Scientific is recruiting on behalf of a leading drug development organisation, and we would be keen to hear from individuals from a Regulatory Affairs background.

Requirements:

This is a fantastic opportunity to join a growing Regulatory Affairs team as Regulatory Affairs Project Manager. In this role, you will be responsible for the preparation, coordination and submission of regulatory applications (CTA, Ethics and ARSAC) as well as ensuring that the quality of these submissions is maintained as appropriate throughout the lifespan of the study.

The role:

  • As a Regulatory Affairs Project Manager, you will act as the regulatory lead for studies within a wider project specific team, providing regulatory advice on submission strategy within the company, as well as regulatory advice and guidance to clients.
  • You will be responsible for reviewing company and client submission documentation and dealing with all post-submission activities including responding to questions from the authorities.
  • You will create and review regulatory submission documents such as IMPDs. and IBs and will also be responsible for the preparation of ARSAC certificate applications where required. 
  • Throughout this process you will act as the primary regulatory point of contact and interact directly with the authorities as required.

The person:

  • The ideal candidate would be educated to degree level in a science subject
  • You will possess a minimum of 3-4 years regulatory affairs experience within the pharmaceutical industry.
  • In addition, the candidate would be able to demonstrate a comprehensive understanding of drug development, the regulatory application and submission process and adhere to legal obligations where required.  

Company and Culture:

Learning and development is at the heart of the culture with my client and you will be given every opportunity to reach your potential with them. You’ll be recognised for your contribution and rewarded with genuine career development, a competitive salary & a whole host of benefits.

Apply for this job: Regulatory Project Manager

Contact Information:

Address:  Head Office
Globe Works, Penistone Road, Sheffield
S6 3AE
England
Tel:  0114 238 0012
Website:  Visit Our Web Site

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