The Regulatory Lead is accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level. Provides leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial applications according to defined milestones and key performance indicators.
- Responsible for managing the planning, implementation and tracking of the clinical trial application delivery & process as well as risk mitigation. Liaises closely with the Global Regulatory Affairs (GRA) on study application.
- Attends meetings with internal and external stakeholders e.g Trial Kick-off Meeting and ad-hoc Trial Oversight Meeting
- Provide support to obtain missing document(s) in case the global documentation dispatch is not complete.
- Ensure timely CTA submission content plan preparation in trial management systems in accordance to the aligned trial initiation strategy and stipulated timeline stated in Global SOP
- Perform final review of submission content plan and provide final decision to initiate actual submission to Health Authority (HA)
- Perform actual submission to Singapore HSA. Update submission and approval dates in trial management system
- Perform final review of Australia CTN Request Form and provide it to Local Regulatory Affairs team to submit the CTN . Ensure submission and approval dates are updated by local RA team in trial management system
- Perform final review of SCOTT form and documents finalized in NZERM portal and inform local Regulatory Affairs team in Australia to submit it to NZ Medsafe.
- Ensure submission and approval dates are updated by local Regulatory Affairs team in trial management system
- Facilitate timely provision of response (Regulatory Affairs related) from GRA to address questions or deficiency letter from local HA
- Maintain CTA Matrix up-to-date at all times
- Support maintenance of regional Kmed
- Support Regulatory Intelligence
- Facilitate and support cross-functional impact analysis for new or updated regulations/requirements for CTA submission to HA. Facilitate and support cross-functional responses/answers to global surveys
Requirements:
- A minimum of a bachelor’s degree in Life Sciences or related scientific field (or equivalent experience) is required.
- Minimum 5 years of start-up, regulatory or clinical project management experience preferred.
- Experienced in Clinical Trial Application (Regulatory submission)
- Experience in APAC region preferred.
- Possesses a specific regulatory or technical expertise. Sufficient knowledge of managing regulatory projects, project deliverables on a time bound manner;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients;
