Operations Regulatory CMC Analyst
A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire an Operations Regulatory CMC Analyst. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK.
- Producing and supporting 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.
- Working in partnership with relevant product and project teams supporting regulatory submissions.
- Coordinating the assembly, including document requests and generation, of submission-ready components to support lifecycle submissions linked to license maintenance and post-approval changes.
- Using AZ authoring tools and house style.
- 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 Operations Regulatory.
- 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 regulatory submission and commitment status is accurately reflected, notifying relevant departments and groups of health authority approvals as they are received.
- Contributing to the CI work of the department.
Skills and Requirement:
- Scientific degree or pharma candidate with some industry experience - essential
- 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.
- 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).
- Must be able to work 5 days a week from Macc / no home working.
Experience in managing documents and writing reports.
- Good attention to detail.
- Ideally from a QA/QC background.
- 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 in 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 Emily Oakley-Keenan at 0203 854 2469 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.