Senior Manager, RA TA Group, Regulatory Affairs(Neurology)
Core
Leading a Regulatory Affairs Therapeutic Area team in Japan to ensure effective workflow, optimal productivity, and delivery of high-quality regulatory outputs for neuroscience products.
Role type
Senior Manager, Regulatory Affairs (Neurology)
Builds
Regulatory submissions and product lifecycle management activities for neuroscience therapies
Domain
Pharmaceutical / Regulatory Affairs / Neuroscience
Deliverable
client delivery
Required skills
Team leadership, project management, regulatory strategy development, stakeholder liaison, compliance management, problem-solving
Preferred skills
Experience in package insert maintenance, knowledge of Japanese regulatory frameworks (PMDA/MHLW)
Technologies
None stated
Responsibilities
Lead and manage the RA TA team by setting clear objectives and performance expectations; Oversee recruitment, onboarding, and ongoing training and development for all team members; Allocate projects and responsibilities based on regulatory and therapeutic area expertise; Mentor and coach team members to support their professional and career growth; Direct involvement in development projects and life-cycle management activities, including Package Insert maintenance; Liaise with key internal and external stakeholders (e.g., PMDA, MHLW, global teams) for cross-functional initiatives; Contribute to regulatory policy intelligence and actively monitor relevant regulatory changes and developments.
Seniority
Senior, hands-on IC with team management