CMC RA Manager at Top Global Pharma

Join a global pharmaceutical leader as a Regulatory Affairs CMC Manager in Japan. This role offers the opportunity to shape regulatory strategies, lead health authority interactions, and contribute to the development and lifecycle management of cutting-edge therapies.

Client Details

• A global pharmaceutical company with a diverse portfolio including small molecules, biologics, vaccines, and cell & gene therapies
• Offers exposure to the full product lifecycle, from early development to post-approval
• Encourages innovation and supports professional growth in a psychologically safe environment
• Strong presence in Japan with direct engagement with PMDA and MHLW
• Active in global regulatory policy and industry associations
• Committed to cross-functional collaboration across R&D, Manufacturing & Supply, and Regulatory Affairs
• Provides opportunities to contribute to global regulatory science and policy initiatives

Description

• Develop and implement innovative Japan regulatory CMC strategies for development and marketed products
• Lead regulatory interactions with PMDA/MHLW, including quality consultations and strategic negotiations
• Manage CMC change controls and regulatory impact assessments for post-marketed products
• Prepare and review high-quality regulatory CMC dossiers in collaboration with global and local teams
• Contribute to global regulatory strategy documents, ensuring alignment with Japan-specific requirements
• Support regulatory inspections (PAI) as a local GMP sub-team lead when required
• Monitor and interpret local and global regulatory guidelines and trends
• Participate in internal and external regulatory policy initiatives and industry associations
• Promote continuous improvement in dossier preparation processes
• Mentor and support team development where applicable

Job Offer

• Opportunity to lead regulatory strategy for innovative therapies
• Hybrid working style
• Exposure to a wide range of modalities and global regulatory frameworks
• Career development in a globally recognised pharmaceutical company
• Competitive compensation and benefits package

Page Group Japan is acting as an Employment Agency in relation to this vacancy.

• Bachelor's degree in a science or health-related field (advanced degree preferred)
• Minimum 3 years of direct Regulatory CMC experience (5+ years preferred)
• Experience in pharmaceutical CMC functions (e.g., QC, manufacturing) desirable
• Strong knowledge of Japan and global regulatory guidelines and dossier requirements
• Proven ability to manage strategic regulatory issues and engage with health authorities
• High fluency in English and Japanese (non-native level speakers will not be selected)
• Experience with regulatory authorities is a plus