Senior Regulatory Executive

6 days left

£72 phr Umbrella
01 Feb 2021
03 Mar 2021
Lucy Stendall
Regulatory Affairs
Full Time
Contract Type
Experience Level
Senior Management
CK Group are recruiting for a Senior CMC Regulatory Executive to join a company in the healthcare industry at their site based in Ware on a contract basis for 7 months.

Up to £72 per hour Umbrella, depending on experience

Senior CMC Regulatory Executive Role:
- Preparation of high quality chemistry, manufacturing and control (CMC) regulatory documents for new, small molecule products, using varied information sources and liaising closely with other company personnel to ensure accuracy of such records.
- Work to agreed deadlines, with ability to respond readily to changing events and priorities.

Your Background:
- CMC Regulatory Affairs experience; planning, authoring, reviewing and project management of regulatory submissions.
- Good written and oral communication. Demonstrated ability to focus, work with attention to detail and retain critical information.
- Degree in Pharmacy, Chemistry or related discipline.
- Global experience, (including EU, US, Japan, China and emerging markets), in the following types of CMC submissions: - Clinical trials documents, - Marketing applications for new medicines and managing the related responses to questions & Post approval variations

Our client is a global healthcare company, taking on some of the world's biggest healthcare challenges.

This Senior CMC Regulatory Executive role will be based at our clients site in Ware, Hertfordshire.

Entitlement to work in the UK is essential. Please quote reference 49758.

Please note that the successful applicant will be required to engage via an FCSA-accredited and CK-approved umbrella company and the rate of pay indicated is an umbrella rate.

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