Associate Director, Regulatory Affairs (Contract)
Core
Manage CMC and clinical regulatory applications for late-stage biologic and gene therapy therapeutics to secure approvals in domestic and international markets.
Role type
Associate Director, Regulatory Affairs (Contract)
Builds
Clinical trial applications and regulatory filings for Phase 3 trials in Japan and China
Domain
Biotechnology / Gene Therapy / Ophthalmology
Deliverable
client delivery
Required skills
Regulatory strategy, CMC regulatory submissions, international regulatory interactions (PMDA, CDE), drug development lifecycle knowledge, GCP/GMP/GLP compliance, regulatory decision-making
Preferred skills
Late-stage Phase 3 development experience, expertise in complex biologics or gene therapy, experience with US/China/Japan regulatory filings
Technologies
Microsoft Word, Outlook, SharePoint, Adobe Acrobat
Responsibilities
Communicate with regulatory agencies regarding submission strategies and responses; Oversee planning and submission of clinical trial applications for Phase 3 trials in Japan and China; Provide regulatory advice to clinical operations and CMC departments; Manage responses to regulatory authority questions and requests
Seniority
Senior, hands-on IC
