Clinical Life Sciences Pharmaceuticals
Salary Competitive Salary
CY Partners have an exciting opportunity for a Regulatory Executive to join a leading global pharmaceutical company, based at their site in Surrey.
As a Regulatory Executive, you will demonstrate your understanding of Global 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 and complete delivery of these documents. As a Regulatory Executive you will also have the opportunity to resolve unexpected issues/challenges and minimize impact by communicating and escalating to peers and senior management when required.
Other responsibilities will include:
• Agreeing and communicating plans required for Regulatory submissions in markets to meet renewal, admin variation and safety reporting timings, expectations and milestones.
• Managing the execution and delivery of ‘Right First Time’ dossiers, ensuring filings for planned initiatives are completed as planned.
• Ensuring 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 seeking 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.
• Contribute as Regulatory representative into priority project initiatives on behalf of the company’s Consumer Healthcare, ensuring adequate Regulatory support is provided to deliver project objectives.
This position is offered on a contract basis. It is an excellent opportunity for a Regulatory Executive to expand on their experience and work with a global company.
For further information please feel free to contact Helen at CY Partners on 0191 477 4733 or [email protected]