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
Builds
Marketing applications and post-approval submissions for life-changing medicines
Domain
Pharmaceuticals, Oncology, Japan Regulatory Affairs
Deliverable
client delivery
Required skills
Japan regulatory strategy, PMDA interaction, marketing application management, post-approval change management, clinical trial notification, local labeling review, business start-up support, compliance management, strategic thinking, matrix teamwork
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, Manage interactions with PMDA and other Japanese health authorities, Lead or support clinical trial notification preparation, Represent Regulatory Affairs in cross-functional teams, Support local labeling and promotional material review
Seniority
Senior Manager, hands-on leadership