Regulatory CMC Associate
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 aglobal 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 CMCdocuments 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 asthey 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 Lucy or Andy on 01246 457725 or email firstname.lastname@example.org, quoting job ref 49077.
It is essential that applicants hold entitlement to work in the UK.