Principal Scientist, Regulatory Liaison - Oncology
Core
Develop and implement global regulatory strategy for oncology, immunology, and device products to optimize labeling and accelerate approval timelines with regulatory agencies.
Role type
Principal Scientist, Regulatory Liaison (Oncology)
Builds
Global regulatory strategies and submissions for investigational and marketed drugs/biologics
Domain
Healthcare / Oncology / Regulatory Affairs
Required skills
Global regulatory strategy, FDA/EMA interaction, regulatory filings, cross-functional leadership, strategic planning, regulatory document review, IND/CSA review, marketing application approval
Preferred skills
Oncology therapeutic area, Immunology/biologics, major region regulatory experience (US/EU/Japan/China)
Responsibilities
Develop worldwide product regulatory strategy to optimize label and obtain shortest time to approval; Provide expert advice to Product Development Teams on regulatory issues throughout the drug lifecycle; Lead the Global Regulatory Team to coordinate cross-functional support; Review and approve local registration study protocols for secondary markets; Represent the company with external organizations (FDA, EMA) and chair advisory committee meetings; Coordinate interactions with foreign agencies and subsidiary registration departments; Review and approve Worldwide Marketing Applications, Clinical Study Reports, and Investigator Brochures; Participate in regulatory due diligence for licensing candidate review
Seniority
Principal, strategy & mentorship