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Job Details

Senior Reg Affairs Officer, CMC

Company: Regulatory Professionals
Location: Buckinghamshire
Reference: J31005
Closing Date: 20 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: Up to £50,000 per annum + Benefits

Job Summary:

Senior Reg Affairs Officer, CMC Regulatory Professionals is working with a top 10 UK pharmaceutical company who specialise in the treatment of pain and provide high quality medicines to patients on a global scale.

Requirements:

Senior Reg Affairs Officer, CMC
Buckinghamshire, UK
Salary: up to £50,000 per annum
Permanent Position
Job Ref: J31005

Regulatory Professionals is working with a top 10 UK pharmaceutical company who specialise in the treatment of pain and provide high quality medicines to patients on a global scale.

Job Responsibilities will include, but are not limited to:
* Being the project manager for CMC documentation for new product development registrations in EU and international markets
* Preparation of CMC strategies for new EU registrations
* Conduct complex post approval changes
* Update CMC Module 3 documentation for ongoing procedures
* Work alongside the project lead to prepare submissions to the relevant regulatory authorities
* Responding to CMC questions

The ideal candidate will possess the following skill set:
* Bachelor's degree in Pharmacy, Chemistry or Life Sciences
* In-depth knowledge of the drug development and manufacturing processes
* Ability to write and update Module 3 and 2.3 dossier CTD sections for post approval activities
* EU market experience
* A minimum of 5 years CMC Regulatory experience, including the preparation of Module 3 dossier in CTD format
* Proven track-record of successfully leading and working in cross functional teams
* Experience with operating Samarind RMS and SAP is desirable
Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully place then you'll receive £250 worth of vouchers of your choice.

CMC, Regulatory, Module 3, new registrations, drug development, Buckinghamshire

Apply for this job: Senior Reg Affairs Officer, CMC

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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