Manager II, RA TA Group, Regulatory Affairs(Immunology)
Core
Lead regulatory affairs activities for complex, high-impact projects in the immunology therapeutic area, ensuring compliance with Japan-specific regulations and driving product lifecycle strategies.
Role type
Manager II, Regulatory Affairs (Japan)
Builds
Regulatory submissions (NDAs, PMDA consultations, Clinical Trial Notifications, package inserts) for immunology products in Japan
Domain
Pharmaceutical / Healthcare / Immunology
Required skills
Japan regulatory expertise (PMDA/MHLW), complex project management, risk assessment and scenario planning, team coaching and talent development, cross-functional strategic partnership
Preferred skills
Mentoring junior team members, leading cross-TA collaboration, process improvement initiatives
Technologies
Regulatory submission platforms, PMDA/MHLW interaction systems
Responsibilities
Lead regulatory submissions to PMDA/MHLW; Serve as regulatory lead in cross-functional project teams; Develop and implement regulatory strategies for complex programs; Act as senior point of contact for PMDA/MHLW interactions; Identify and manage regulatory risks; Coach and train RA team members; Contribute to team management and cross-TA collaboration
Seniority
Manager II, hands-on IC with leadership responsibilities