Senior Regulatory Executive (CMC)

  • Salary: £392.30 per day PAYE
  • REF Number: 00048391
  • Consultant: Lucy Stendall
  • Contact: 01246 457725
  • Date Published: 03.07.2020
  • Sector: Non-Specific
  • Location: Uxbridge, London
  • Discipline: Regulatory Affairs

CK Group are recruiting for multiple Senior Regulatory Executives to join a company in the Pharmaceutical industry at their site based in Uxbridge on a 12 month contract basis initially.

The Company:

As a global healthcare company, they take on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.

The Location:

Stockley Park was the UK's first and most successful business park. Situated close to Heathrow Airport in West London, it is home for roles within clinical safety, clinical data, conversion leads, programming, regulatory and more. It's a location that combines excellent transport links with the M4 and M25 motorways and Heathrow Airport a few minutes away. A choice of railway and tube stations, extensive bus networks plus ample parking provides a coordinated transport hub to connect to the park.

The Role:

  • Preparation of high quality, Chemistry, Manufacturing and Control (CMC) detailed regulatory documents using varied information sources. liaising closely with other company personnel to ensure accuracy of such records.
  • Working to agreed deadlines and maintaining records to reflecting project status.
  • Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice.

Your Background:

  • CMC authoring experience essential (previous co-ordination role is not sufficient). This should include authoring of module 3 and authoring of CMC variations.
  • Post Approval CMC experience preferential.
  • Understands CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
  • Experience responding to manufacturing site change controls and providing regulatory advice and strategies.

Apply:

For more information or to apply for these Senior Regulatory Executive positions, please contact Lucy on 01246 457725 or email pharmacontracts@ckagroup.co.uk, quoting job ref 48391.

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

CLINGEN

We'll store this in session so if you're applying for multiple jobs today so you can use this as a base.