Senior Regulatory Executive (Regulatory Records & Data Management)
- Stockley Park, Middlesex (GBR), London, ENG (GBR)
- £450 - £500 Per Day
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00079529
- compliance
- change control
- metrics
- regulatory
- data management
- operations
- healthcare
- pharmacovigilance
- implementation
- gmp
Senior Regulatory Executive (Regulatory Records & Data Management)
GSK Stockley Park
12 Month Contract
Pay: up to £500 per day
Role Description:
To ensure the data quality and consistent and effective use of registration data systems in order to support GSK’s Regulatory and Pharmacovigilance obligations, GMP-compliant product supply and business efficiency across the GSK Pharmaceuticals Regulatory Function.
In this role, the position holder will be responsible for ensuring delivery of Regulatory Records & Data Management (RRDM) initiatives and projects and oversight of operational teams ensuring the timely execution of RRDM based requests.
- Efficiently deliver on-time completion of all Regulatory Records & Data Management (RRDM) activities assigned in compliance with internal and external procedures/regulations
- Lead and motivate teams of Regulatory Records & Data Management associates, ensuring appropriate knowledge and competency is built and maintained to support existing and emerging workload
- Lead initiatives and projects to support evolving internal and external regulatory requirements impacting our Regulatory Information Management processes such as Registration Tracking, EVMPD, IDMP and CMC Technical Details
- Partner with GRPD Regulatory Systems, GSK IT and external vendors to optimize delivery and use of regulatory data management systems and associated processes
- Collaborate with Regulatory Operations functions in GSK Vaccines and GSK Consumer Healthcare to maximize the alignment and efficiency of Registration Data Management across these Business Units.
- 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.
- Identify cases of potential non-compliance with internal and external procedures and follow appropriate procedures to investigate and, where necessary, identify risks, appropriate corrective actions and prevent future issues
- Develop metrics, evaluate and improve performance of the RRDM team.
All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.
