Associate II Reg Strategy, GRS Oncology
Core
Coordinate lifecycle regulatory submissions and CMC operations for oncology products to ensure global compliance and patient access.
Role type
Associate II Regulatory Strategy (Oncology)
Builds
Lifecycle maintenance submissions, CMC Module 1 documents, safety compliance reports, and labeling updates.
Domain
Pharmaceutical regulatory affairs (Oncology)
Required skills
Regulatory strategy, lifecycle maintenance submissions, CMC document preparation, electronic application authoring, quality control, stakeholder coordination, cross-functional collaboration, process improvement, data tracking, health authority response management.
Preferred skills
Oncology portfolio experience, biologics knowledge, eAF and regulatory information management systems proficiency, process automation, data analytics.
Technologies
eAF, document management systems, regulatory information management systems.
Responsibilities
Coordinate variations, supplements, renewals, and withdrawals; prepare and QC electronic submission packages; support labeling updates and safety reports; manage Health Authority queries; collaborate with global and regional teams.
Seniority
Associate II, hands-on IC