Regulatory Project Lead
Life Sciences Pharmaceuticals
CY Partners are looking for a Regulatory Project Lead to join a global pharmaceutical organisation based in Brentford.
As a Regulatory Project Lead you will demonstrate your regulatory knowledge of requirements and global submissions for an assigned product in development or marketed product; planning own and submission team activities to ensure delivery to agreed time frames and appropriate content.
Other responsibilities will include:
- Implementation of the submission strategy for TG supported markets
- Development and implementation of the submission strategy for NCE Global Delivery supported markets
- Ensuring quality of both own and submission team work and compliance with regulatory guidelines and process as they apply to the role.
- Working with staff from other functions, and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidances, 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
This role is offered on a contract basis, working from home initially and provides an excellent opportunity for a Regulatory Project Lead with experience of working on a global level to further develop their experience and leadership.
Get in touch with Helen at CY Partners for a confidential chat about the role on 07851246847 or submit your CV to [email protected] to apply for the position now.