Manager, Regulatory Affairs Strategy - Oncology
Core
Coordinate global regulatory submissions and manage agency interactions for novel oncology therapeutics.
Role type
Manager, Regulatory Affairs Strategy
Builds
Regulatory filings (INDs, CTAs, Orphan drug applications) and briefing documents for novel therapeutics
Domain
Biopharmaceuticals / Oncology
Deliverable
client delivery
Required skills
Regulatory submission coordination, agency query management, drug development process knowledge, CRO interaction, project prioritization
Preferred skills
US FDA and international guidance expertise, ex-US/ex-EU CTA management experience
Technologies
None stated
Responsibilities
Coordinate preparation and submission of global regulatory submissions; Assist in coordination and preparation for Agency meetings; Lead and track queries and commitments with regulatory agencies; Provide representation for study-level regulatory activities
Seniority
Manager, hands-on IC