ProClinical is advertising a vacancy for a CMC Analyst position with a global biopharmaceutical company. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide. The role will be based with the company's office in Manchester.
The Regulatory CMC Associate within Operations Regulator is a Dossier Manager role. 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.
- 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.
Skills and Requirements:
- 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.
- 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).
- Demonstrated project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Numhom Sudsok at +44 203 871 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.
€0.00 - €120000.00 per annum
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