Senior Manager, Regulatory Affairs
Core
Lead Japan regulatory strategies and PMDA consultations for oncology and other therapeutic areas, managing marketing applications and post-approval changes.
Role type
Senior Manager, Regulatory Strategy (Oncology & Japan Affairs)
Builds
Regulatory submissions and approvals for life-changing medicines in Japan
Domain
Pharmaceuticals / Oncology / Japan Market
Deliverable
client delivery
Required skills
Japan regulatory strategy, PMDA interaction management, marketing application submissions, post-approval change management, clinical trial notification, local labeling review, business start-up support, compliance with Japanese standards
Preferred skills
Master's degree in scientific discipline, experience in business start-up activities
Technologies
None stated
Responsibilities
Plan and execute Japan regulatory strategies and PMDA consultations, Lead marketing application and post-approval change submissions, Partner with local and global leadership to support Regulatory Affairs operations, Manage interactions with PMDA and other Japanese health authorities, Lead or support clinical trial notification preparation and submission activities, Represent Regulatory Affairs within clinical, commercial, medical, and patient safety teams
Seniority
Senior Manager, hands-on leadership
