Head of RA
Core
Lead regulatory strategy, operations, and compliance for Galderma's Japan market, serving as the Marketing Authorization Holder General Manager (Sokatsu) for medical devices and skincare.
Role type
Senior IC Head of Regulatory Affairs (Japan)
Builds
Regulatory strategies, product registrations, and compliance frameworks for medical devices and dermatological skincare in Japan.
Domain
Healthcare / Dermatology / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy, QMS knowledge, Japanese regulatory authority negotiation, team leadership, risk management, compliance oversight, stakeholder management, project management, change control, lifecycle management.
Preferred skills
Medical device regulatory experience, global matrix organization experience, new product launch leadership, vigilance system oversight, industry association representation.
Technologies
RIMS, SOPs, WI, Global Policy frameworks
Responsibilities
Provide strategic regulatory advice to the Japan leadership team; Fulfill Sokatsu responsibilities; Lead regulatory submissions and interactions with health authorities; Oversee license maintenance and vigilance systems; Manage cross-functional collaboration on regulatory alignment; Lead and develop RA, Quality, and Vigilance functions.
Seniority
Senior, hands-on IC with leadership responsibilities
