SRG are currently looking for two Regulatory Senior Executive's for a Global Pharmaceutical Company who have opened new vacancies within their Regulatory team to be based at their offices in Middlesex (moving to London mid contract) on a contract running to the end of 2020 with the possibility of extension.
Ensures that company product (Pharmaceuticals and Vaccines) registration information and regulatory records are maintained to a standard appropriate to support critical regulated processes including Pharmacovigilance and GMP-compliant product supply. This data also supports the efficient operational management of the Regulatory function, worldwide. The role provides operational support to Regulatory Information Management Systems (RIMS) end-users.
- Support IT projects in user roles such as requirements definition, data migration and user acceptance testing
- Independently manages multiple project assignments in the area of responsibility simultaneously; assignments will range in complexity but more complex work is expected
- Collaborate with Regulatory Operations functions in Vaccines and Consumer Healthcare to maximize the alignment and efficiency of Regulatory Information Management Systems across these Business Units.
- Develop, maintain and deliver training and support material, including Written Standards, to ensure appropriate and consistent use of Regulatory Information Management Systems.
- Independently completes data assessment/data maintenance tasks/complex submission packages to ensure output is fit for purpose.
- Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products/registration data management/submission format to expedite submission, review and approval of global applications.
- Define, implement and oversee data quality monitoring procedures including regular data entry checks and the identification, investigation and remediation of quality issues
- Complete time-critical operational tasks when appropriate
- Define system procedures, including reports, to support Business Processes effectively and manage change control procedures to ensure full impact assessment and robust implementation of change.
- Monitor ongoing user requests and system activity to identify and act upon potential quality issues or process improvement opportunities
- Support the RRDM Operations team in analyzing and resolving user requests and issues
- Bachelor's degree minimum in any life sciences
- 7+ years' relevant experience within a regulated or quality-critical environment (e.g. Pharmaceutical Industry Regulatory) of which 5+ years of experience in Regulatory Information Management Systems
- Understanding of regulatory procedures and their applicability within Regulatory Information Managements Systems (RIMS).
- Well-developed understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
- Data analysis skills using Microsoft Excel and/or other tools
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@srgtalent.com or +441753 589673
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