Associate Director, Regulatory Submissions
Core
Lead the Study Start-Up group in the APAC region, driving strategic development, process improvement, and client relationships for clinical trial initiation.
Role type
Senior IC clinical operations manager (Study Start-Up)
Builds
Clinical trial start-up activities and regulatory submissions for biotech, pharma, and medical device clients
Domain
Clinical research / Contract Research Organization (CRO)
Required skills
Study Start-Up leadership, regulatory submission expertise, client relationship management, strategic planning, process improvement, project leadership
Preferred skills
Advanced degree in life sciences, oncology/cardiology/metabolic/CNS/anti-viral therapeutic area experience
Technologies
Clinical trial management systems, regulatory submission platforms
Responsibilities
Lead and oversee Study Start-Up/Regulatory Submission activities and timelines; Develop and maintain relationships with clients; Contribute to new business development opportunities; Drive strategic development and continuous improvement of internal processes; Support local Australian team development
Seniority
Senior, hands-on IC with leadership responsibilities
