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Job Details

Regulatory Manager CMC

Company: Hobson Prior
Location: Cambridgeshire
Reference: PV455241
Closing Date: 07 Sep 17
Type: Permanent
Salary (£): On Application
Benefits: £55,000

Job Summary:

In conjunction with line manager, plan, manage and execute regulatory CMC activities to support medicinal product/drug device combination marketed products and development program. Work within matrix team (Regulatory strategy, US regulatory, Pharmaceutical development, Medical device regulatory, Manufacturing, Quality etc) in addition to external CRO team members and partners.

Requirements:

Role;

In conjunction with line manager, plan, manage and execute regulatory CMC activities to support medicinal product/drug device combination marketed products and development program.
Work within matrix team (Regulatory strategy, US regulatory, Pharmaceutical development, Medical device regulatory, Manufacturing, Quality etc) in addition to external CRO team members and partners.
Author, compile and review regulatory submission documentation (QOS and Module 3).
Co-ordinate regulatory CMC activities for Clinical Trial Applications (CTAs), Investigational New Drug submissions (INDs), responses to Regulatory Agency questions, maintenance of CTA/IND approvals as required by project team, scientific advice requests, PIP processes, MAA/NDA submissions.

 

Experience;

Experience in regulatory CMC activities with focus on EU and ROW.  Understanding of drug development and regulatory CMC
Ability to work well both independently and in a team environment, in a matrix function and across various international territories
Knowledge of international CMC documentation requirements

 

 

 

 

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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