Operations Regulatory CMC Analyst
ProClinical is advertising a vacancy for an Operations Regulatory CMC Analyst with an international pharmaceutical company. This organisation, which delivers leading products across various therapeutic areas, is offering an exciting opportunity to join its team in Cheshire on a contract basis.
The Operations Regulatory CMC 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. They will also partner with relevant products and project teams, providing regulatory and compliance advice.
- Coordinating the assembly, including document requests and generation, 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 Regulatory Operations.
- Working in partnership with stakeholders across Operations (including technical functions and manufacturing sites) and Global Regulatory Affairs.
- Advising on CMC regulatory and compliance focused aspects of post-approval regulatory submissions.
- Supporting the progression and delivery of cross-functional documentation required by Global Regulatory Affairs for inclusion in worldwide regulatory submissions.
- Maintaining electronic systems to ensure the current regulator submission and commitment status is accurately reflected, notifying relevant departments, and groups of health authority approvals as they are received.
- Sharing knowledge and learning gained from own projects with colleagues within and outside the department as appropriate.
Skills and Requirements:
- A Bachelors' degree in an scientific discipline, such as chemistry, pharmacy, or biological science. Alternatively, applications that show at least 4 years of experience in a Regulatory Affairs, Quality Assurance, or R&D role linked to the pharmaceutical industry will be considered.
- Solid knowledge of the drug development process and regulatory submissions.
- Demonstrable experience in Pharmaceutical Production, Regulatory Affairs, Quality Assurance, R&D.
- Understanding of current regulatory CMC requirements and the contents of Modules 1, 2, and 3 of the Common Technical Dossier (CTD).
- Demonstrable experience with Quality & Compliance Management.
- Solid Regulatory knowledge, as well as an awareness of End to End Supply Chain principles and Quality Risk Management principles.
- Strong interpersonal skills, including communication, leadership, relationship management, and influencing.
- Demonstrable IT skills.
- A flexible mindset that is suited to dealing with multiple projects in a timely manner.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on +44203 871 8093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Warren, New Jersey
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