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Regulatory Affairs Specialist

Berkshire   •  £40000 - £45000 per annum  •  Permanent, Full time

Steve Lord at CK Clinical is recruiting for a Regulatory Affairs Specialist to join a small pharmaceutical company at their site based in Reading on a full time permanent basis

The Company:
Our client is a small pharmacetutical with products already on the market. This is a new position as the company is growing, there are opportunities to establish yourself within the business and team.

The Location:
This position is based at the company offices to the west of Reading, with easy access both by rail and Motorway M4.

The Role:
This position will play a key role in regulatory affairs for the company. You will be coordinating consultants, raising relevant regulatory documentation, covering compliance for US/EU and working on pharma and med device regulatory affairs.

Key Responsibilities:
- Guiding the process for submissions, (but not doing the submissions).
- Working on a broad range of projects - from OTC medicines, to generics and medical devices.
- Be responsible for processes and SOP's, ensuring correct regulatory procedures are in place.
- Working closely with compliance, you will help to lead improvements in their QMS management systsem.
- You will also need to work closely with PV consultants.
- Within a small company the business needs can change and you will need to be flexible and take on other tasks as and when assigned.

Your Background:
- Degree educated, preferably life sciences or related subject.
- Strong pharmaceutical and/or medical device experience.
- EU/US experience of regulatory affairs.
- Opportunity to join a small company and develop own career.

This client has solid financial backing and resource support from a larger parent company, with strong growth plans in place. With the smaller company this means there is the chance to get involved in a wide range of areas, not usually open within regulatory affairs.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46824 in all correspondence.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Stephen Lord
  • Phone: 01246 457722
  • Reference: 46824
  • Posted: 25th October 2019
  • Expires: 22nd November 2019

CK Group

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