Regulatory Project Lead
Clinical Life Sciences Pharmaceuticals
Location Stockley Park
Regulatory Project Lead
An exciting opportunity has come up for an experienced regulatory project lead to join a global pharmaceutical company at their site in Stockley Park, initially on a 6-month contract basis. The main scope of the regulatory project lead is to ensure that appropriate content for a range of submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with company process and policy as they apply to the role.
- Accountable to GRL/ Regional Rep/ C&EP lead for delivery of submissions or strategy components for an assigned product in development or marketed product; planning own and submission team activities to ensure delivery to agreed timeframes and appropriate content
- Responsible for the implementation of the submission strategy for TG supported markets
- Responsible for the development and implementation of the submission strategy for NCE Global Delivery supported markets
- Ensures quality of both own and submission teamwork and compliance with regulatory guidelines and process as they apply to the role.
- Works with staff from other functions, and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidelines, researching topics and resolving issues.
- May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
- May be part of the Regulatory Matrix Team for the given product and accountable for leadership of relevant submission team.
- May be responsible for the maintenance activities associated with an approved product, including product renewals, label harmonization, PBRER submissions etc
Ideally candidates will be educated to degree level (or equivalent) in Biological or healthcare science or relevant related discipline, and possess extensive experience within Regulatory Affairs in a Drug development environment. Candidates will also have significant global/EMAP Regulatory submission experience – knowledge of regulatory agency guidelines and expectations for submissions.
If you feel this is the role for you, apply now with your CV, and feel free to contact Tom Kirkpatrick at CY Partners for more information.