Description
We are seeking a Regulatory Affairs Specialist to collaborate with Site Readiness stakeholders and cross-functional teams to ensure client-centric delivery in a matrix organisation.
The successful candidate will provide oversight and accountability for Regulatory Authority (RA) submissions and coordinate activities related to Independent Review Board (IRB)/Ethics Committee (EC) and Third Body submissions for designated projects within Site Readiness.
Responsibilities:
- Provide oversight and accountability for RA submission planning, timeline management, and delivery in accordance with agreed-upon timelines.
- Coordinate responses to RA queries and ensure that required response timelines are met.
- Provide consolidated country requirements and regular status updates to the project team and client, as applicable.
- Ensure that RA submission deliverables comply with applicable regulations, guidance requirements, and client requests.
- Present at and attend external and internal meetings, including project core team and client meetings.
- Initiate improvements to enhance the efficiency and quality of the submission work performed on assigned projects.
- Coordinate with local and functional stakeholders to support IRB/EC and Third Body submission activities, as applicable.
- Provide regulatory guidance and advice on regulatory issues related to RA submissions and associated start-up activities.
- Evaluate the impact of clinical and regulatory changes on assigned projects.
- Coordinate with local teams to support interactions with regulatory authorities, IRBs/ECs, and Third Bodies on behalf of clients.
- Serve as the primary point of coordination for RA-related communications, as applicable.
- Review and provide input into Start-Up project plans.
- Distribute, implement, and monitor compliance with Start-Up project plans for RA submissions and support coordination activities related to IRB/EC and Third Body submissions.
- Ensure RA submission deliverables are met within required timelines while maintaining awareness of Green Light (GL) approval and Ready-to-Enroll (RTE) milestones.
- Support the tracking of IRB/EC and Third Body milestones and proactively identify and escalate to the Start-Up Lead any risks that may affect submission deliverables or site activation timelines.
- Manage projects according to the billing guide to ensure that work is performed within budget.
- Proactively engage in both quality assurance and risk management activities to ensure that assigned RA submission deliverables are met.
- Contribute to the development of the group by participating in process improvement initiatives, such as developing and updating SOPs.
- Mentor more junior Site Readiness team members.
Qualifications:
- Bachelor’s Degree in Life Sciences or equivalent.
- Working knowledge of ICH-GCP and applicable clinical trial regulations.
- Working knowledge of regulatory authority submission processes is required; familiarity with IRB/EC and Third Body submission processes is preferred.
- Native-level Japanese language skills and business-level English proficiency are required.
Experience:
- Minimum 4 years of experience in Clinical Trial Start-Up, Regulatory Affairs, Clinical Operations, or Drug Development within the pharmaceutical, biotechnology, or CRO industry.
- Experience managing or coordinating RA submissions is required.
- Experience supporting IRB/EC submissions, site activation activities, or clinical trial start-up activities is preferred.
- Experience with Japan Clinical Trial Notification (CTN) submissions, including the coordination of responses to related PMDA queries, is required.
Physical Demands/Work Environment:
- Office environment.
- Some flexibility in scheduling may be required.