CMC Manager (Biologics)

Location: Tokyo, Japan

Company

Pharmaceutical organization focused on product development and regulatory support throughout the product lifecycle.

What you will do

• Prepare CMC components for NDA, CTD, PCA, MCN, and consultation dossiers.
• Prepare and update CMC documents for CTN submissions.
• Execute Japan-specific product strategies in alignment with global regulatory strategies.
• Participate in project teams and PST as the local CMC expert.
• Interact with Japanese health authorities and provide CMC information for investigational products and medical devices used in clinical trials.
• Coordinate cross-functional matters with JAPAC RA-CMC, Japan RA, Japan QA, Dev Ops, and external vendors.

Requirements

• More than 10 years of experience in regulatory CMC and/or CMC operations in the pharmaceutical industry.
• Experience supporting PMDA consultations, CTN, and NDA submissions in Japan.
• Local regulatory knowledge and experience specific to CMC.
• Regulatory knowledge and experience with biologics and chemical products.
• Communication skills in Japanese and English are required.
• Ability to work as a team player and use Microsoft Outlook, Word, Excel, PowerPoint, and Project.

Nice to have

• Master's or doctoral degree.