Global Regulatory Affairs CMC: Senior Manager & Manager - Japan
Core
Shape CSL's regulatory CMC strategy in Japan, partnering across Global Regulatory Affairs, R&D, Manufacturing, and local business teams to support the development, registration, and lifecycle management of the product portfolio.
Role type
Senior Manager / Manager, Regulatory Affairs CMC (Biopharmaceuticals)
Builds
Regulatory submissions (NDAs, variations, renewals, clinical trial applications) and lifecycle management for biologic and plasma-derived products
Domain
Biopharmaceuticals / Plasma-derived products / Japanese regulatory landscape
Deliverable
client delivery
Required skills
Strategic guidance on regulatory pathways, preparation and review of CMC regulatory filings, subject matter expertise in Japan CMC requirements, representation in health authority interactions, cross-functional partnership, risk assessment, mentoring
Preferred skills
Experience with biologic and/or plasma-derived products, advanced degree (MS, PhD)
Technologies
None stated
Responsibilities
Lead and execute Japan regulatory CMC strategies; Manage preparation, review, and submission of CMC regulatory filings; Serve as subject matter expert for Japan CMC regulatory requirements; Represent CSL in interactions with Japanese health authorities (PMDA, MHLW); Partner with cross-functional stakeholders; Provide regulatory leadership on business-critical issues; Mentor and support matrix team members
Seniority
Senior Manager (8-10 years) / Manager (5+ years), hands-on IC with strategic guidance
