Senior Manager, CMC Global Regulatory Affairs

Job Summary

Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka’s products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing.

• Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug-device combination products.
• Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and inquiries.
• Represents CMC RA in project team meetings and provides regulatory guidance and perspective to the cross‑functional team in conjunction with global regulatory lead(s).
• Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements.
• Develop and execute regulatory strategies for post‑approval changes for marketed products and communicate with respective cross‑functional teams. Provide regulatory strategies on CMC changes for development phase products.
• Prepare departmental job procedures.
• Interact with manufacturing and quality groups, partner organizations, regarding CMC issues.
• Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and reports within company timelines and in accordance with regulations and guidelines.
• Develop and maintain collaborative relationships with other local and/or global functional units [OPCJ CMC RA, Factory, Quality, MPDD, OPDC/OPEL Tech Ops] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc.
• Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings.
• Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.
• Independently handle monthly meetings with global cross‑functional teams for assigned products.
• Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Trackwise, TRS Viewer, Concur (expenses), and Microsoft office tools.
• Performs other duties as assigned.

• Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues.
• Knowledge of CMC regulatory requirements for biologics and small molecules during development and post‑approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products.
• Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canada.
• Comprehensive understanding of the global regulatory environment.
• Proactive strategic thinker.
• Operationally minded (know how to prepare a high quality technical document or submission using internal systems).
• Strong analytical, problem‑solving, organizational and negotiation skills.
• Strong collaborative inter‑person, communication, presentation and meeting leading skills.
• Strong ability to work in a matrix environment and across cultural lines.
• Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• 7 years CMC regulatory experience in the pharmaceutical industry with a history of successful investigational filings and approvals of marketing applications as the CMC Regulatory lead.
• Regulatory experience in handling controlled substance applications will be a plus.

• Similar knowledge of EMA, Latin America and Middle‑East countries will be a plus.
• 3–5 years of hands‑on pharmaceutical product development, including scale‑up and technology transfer to manufacturing and/or manufacturing experience is…