Regulatory Affairs Compliance Manager
A new opportunity has arisen for a Regulatory Affairs Compliance Manager to work closely with QA, Technical Operations and other regulatory experts to ensure regulatory compliance of third-party manufacturers. The organisation based in Basildon are looking for highly motivated individuals, with strategic thinking to join our growing organization and establish a new regulatory compliance team.
- To support compliance of contract manufacturing sites in the validation and production of licenced products.
- Providing regulatory compliance support to 3rd party manufacturing sites producing the products.
- Review and/or approval of master manufacturing documentation.
- Design of process validation strategy and review of protocols.
- Support Technical Operations in overseeing all process validations relating to 3rd party manufactured and licenced products, providing timely review and approval as necessary.
- Work with the regulatory strategist to define the necessary licence variations ahead of the validation plan.
- Communicate compliance issues and mitigation plans relating to 3rd party manufacturers to all relevant departments.
- Co-ordinating activities of the of the regulatory compliance group to ensure adequate and timely support to regional markets.
- Responsible for the maintenance and approval of master manufacturing documentation, testing specifications and analytical methodology from 3rd party manufacturers.
- Summarise the key registered details to provide a working business document and increase visibility to the operations teams
- Review supply chain maps to ensure these align with the registered sites of activities.
Skills and Requirements
- Bachelor's degree is required. Scientific/health field
- Generally, has at least 10 years of related experience within a pharmaceutical company, CRO, CMO or similar organization.
- A sound understanding of pharmaceutical manufacturing practices with >5 years experience in this field.
- An understanding of the pharmaceutical regulatory system.
- Experience in establishing processes and systems relevant to the management of master production records.
- Strong knowledge of MS Word, Excel, PowerPoint, Project and Outlook.
- Ability to work independently, take initiative and complete tasks to deadlines.
- Fluent German, Italian or French
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 Dominic Cappell on 02039671074 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.