Regulatory Executive (Consumer Healthcare)
(PART TIME ONLY - 18.75 HOURS PER WEEK)
10 Month Contract
Pay: up to £45 per hour
- Comprehensive understanding of Global Regulatory requirements, specifically for maintenance activities such as renewal application and post-launch variations, so to efficiently plan and communicate these requirements to stakeholders to ensure timely & complete delivery of these documents.
- Agree & communicate plans required for Regulatory submissions in markets to meet renewal, admin variation and safety reporting timings, expectations and milestones.
- Manage the execution and delivery of ‘Right First Time’ dossiers, ensuring filings for planned initiatives are completed as planned.
- Prepare/ensure availability of high quality documents required to support renewal, admin variations and safety reporting applications and ensure maintenance and lifecycle management in accordance with market data requirements.
- Proactively seek updates and changes in Regulatory Intelligence for market requirements and communicate these to relevant stakeholders.
- Partner with Central Regulatory colleagues (ie CMC), Medical/Clinical, Manufacturing and LOCs to ensure clear communication and understanding of priorities, planned activities (i.e. renewals) and process requirements.
- Contributes as Regulatory representative into priority project initiatives on behalf of GSK Consumer Healthcare. Ensure adequate Regulatory support is provided to deliver project objectives.
- Display ability to resolve unexpected issues/challenges and minimize impact by communicating and escalating to peers and senior management when required.
- Competence & confidence in using required IT Regulatory systems.
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.