My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team. They are looking to recruit a Regulatory Dossier Manager on an initial 12 Month contract basis to their offices in the Macclesfield.
As a dossier manager you will produce and support the production and regulatory submission of Chemistry, Manufacturing and Control 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
- 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
- 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
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@SRG.co.uk or +441753 589673