Senior CMC Regulatory Executive
CK Group are recruiting for a Senior CMC Regulatory Executive to join a company in the healthcare industry at their site based in Brentford on a contract basis for 12 months.
Company: Our client is a global healthcare company, taking on some of the world's biggest healthcare challenges.
Location: This Senior Regulatory Executive role is based at our clients site in Brentford, Greater London.
Salary: Up to £515 per day Umbrella, depending upon experience.
Senior CMC Regulatory Executive Role:
- Preparation of high quality, Chemistry, Manufacturing and Control (CMC) detailed regulatory documents using varied information sources. liaising closely with other business 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.
- Post Approval CMC experience is essential.
- CMC authoring experience essential (previous co-ordination role is not sufficient). This shouldinclude authoring of module 3 and authoring of CMC variations.
- Experience responding to manufacturing site change controls and providing regulatory advice and strategies.
- Detailed proven CMC knowledge and experience for EU and EMAP region.
- You will understand CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Ability to manage multiple project assignments/teams simultaneously and provide data assessment and conclusions.
Apply: For more information or to apply for this Senior CMC Regulatory Executive position, please contact Julie on 01438 870011 or email firstname.lastname@example.org, quoting job ref 50937.
It is essential that applicants hold entitlement to work in the UK.
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.