Senior Director, Global Regulatory Strategy, Oncology
Core
Lead global regulatory strategy for novel, first-in-class oncology therapeutics from early development through commercialization.
Role type
Senior Director, Global Regulatory Strategy
Builds
Global regulatory pathways and registration strategies for mRNA oncology programs
Domain
Biopharmaceuticals / Oncology / Regulatory Affairs
Deliverable
client delivery
Required skills
Global regulatory strategy, IND/CTA/BLA/MAA submissions, health authority negotiations (FDA/EMA/PMDA), oncology therapeutic expertise, CTD format, competitive strategy development, team leadership, risk mitigation, cross-functional partnership
Preferred skills
Graduate degree in scientific discipline, major application delivery (NDA/BLA/MAA/JNDA), experience with novel regulatory pathways
Technologies
CTD format, mRNA platform
Responsibilities
Lead global regulatory strategies from early development through commercialization; Drive regulatory submissions (INDs, CTAs, BLAs/MAAs); Lead health authority interactions (FDA, EMA, PMDA); Shape strategies for novel and first-in-class therapies; Build and develop high-performing regulatory teams; Anticipate regulatory risks and proactively mitigate them
Seniority
Senior Director, enterprise-level strategy & team leadership