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Regulatory CMC Associate

Employer
CK Group
Location
Macclesfield
Salary
£15-17 per hour PAYE
Closing date
21 Oct 2020

View more

Sector
Regulatory Affairs
Contract Type
Contract
Hours
Full Time

Job Details

CK Group are recruiting for a Regulatory CMC Associate to join a company in the Pharmaceutical industry on a contract basis for 12 months. This position will initially be remote, but will move to on-site in the future.

Company:

Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.

Location:
This Principal Clinical Study Data Manager role will be based at our clients site in Macclesfield.

Regulatory CMC Associate Role:
The Regulatory CMC Associate will produce and support the production and regulatory submission of Chemistry, Manufacturing and Control (CMC) documentation for global commercial products at various stages of the product life-cycle.

Key accountabilities will include:
  • Coordinating the assembly of submission-ready components to support lifecycle submissions linked to license maintenance and post approval changes.
  • Supporting the timely delivery and submission of post approval CMC documentation to marketing companies and health authorities.
  • Reviewing and approving regulatory CMC documents on behalf of Operations Regulatory.
  • Maintenance of electronic systems to ensure the current regulatory submission and commitment status is accurately reflected, notifying relevant departments and groups of health authority approvals as they are received.

Your Background:

Required skills & knowledge:
  • Graduate in a scientific discipline.
  • Proven regulatory CMC experience in the pharmaceutical industry is essential.
  • Understanding of current regulatory CMC requirements.
  • Basic knowledge of the drug development process and regulatory submissions.
  • Excellent attention to detail and organisational skills.

Apply:
For more information or to apply for this Regulatory CMC Associate position, please contact CK Group, quoting job ref 49077.

It is essential that applicants hold entitlement to work in the UK.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Company info
Website
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB

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