Regulatory CMC Associate
CK Group is recruiting for a Regulatory CMC Associate to join a company in the Pharmaceutical industry at their site based in Macclesfield on a contract basis for 12 months and has an hourly rate of up to £45 LTD.
The 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.
The Location: This role is located in Macclesfield which is East of Cheshire, on the River Bollin. It is close to the county borders of Greater Manchester to the north, Derbyshire to the east and Staffordshire to the south. It is a gateway to the Peak District and Cheshire Plains, and has breath-taking countryside, parks, rivers, canals, reservoirs and woodland to explore.
The Role: The Regulatory CMC Associate within Operations Regulator is a Regulatory CMC Analyst/Dossier Manager. As a dossier manager you will produce and support the production and regulatory submission of Chemistry, Manufacturing and Control (CMC) documentation for commercial products at various stages of the product life-cycle, in the required format and to the agreed timetable. You will work in partnership with relevant product and project teams support regulatory submissions.
Key Accountabilities include:
- Coordinate the assembly, including document requests and generation, of submission-ready components to support lifecycle submissions linked to license maintenance and post approval changes.
- Support the timely delivery and submission of post approval CMC documentation to marketing companies and health authorities
- Review and approve regulatory CMC documents on behalf of Operations Regulatory
- Support the progression and delivery of cross-functional documentation required by Global Regulatory Affairs for inclusion in worldwide regulatory submissions
- 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
- Contribute to the CI work of the department,
- Insight into the regulatory world.
Your Background: Required Skills & Knowledge:
- Graduate in a scientific discipline e.g. chemistry, pharmacy or biological science or experience in the Pharmaceutical industry preferably within a regulatory QA or QC environment.
- Excellent IT skills
- Excellent written and spoken English
- Delivery focus with ability to effectively manage workload
Preferred Skills & Knowledge:
- Basic knowledge of the drug development process
- Experience of authoring technical documents
- Understanding of current regulatory CMC requirements and the contents of Modules 1, 2 and 3 of the Common Technical Dossier (CTD)
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email email@example.com. Alternatively, please click on the link below to apply online now. 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 47144 in all correspondence.