Associate Director, RACMC-Portfolio Products - Biologics

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. JOB SUMMARY The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio NDAs/BLAs consistent with the company goals, specifically for the life-cycle management of drug product applications. This individual will be responsible for working on cross-functional teams, developing, and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC submissions, and interacting with Health Authorities to meet the aggressive timelines for the assigned projects. The individual will also contribute to regulatory process optimizations on relevant topics. RESPONSIBILITIES Supports CMC regulatory compliance activities for portfolio drug products to meet US, International Conference on Harmonization (ICH), and other applicable regulations. This includes authoring, reviewing, and approval of CMC documentation for NDA/BLA Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation is complete, well organized, scientifically sound, of a high quality, aligned with the current regulations, and presented in a manner that facilitates Health Authority reviews. Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio drug products and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change implementation. Coordinates with regional/global RACMC, Quality Assurance, Pharmaceutical Technology, Supply Chain and other functional areas to secure successful and timely approval of CMC changes and assess regulatory implications. Authors and reviews CMC documentation for supplemental NDAs/BLAs, Comparability Protocols, Validation Studies, Stability Studies, Shipping Studies, etc. Participates in meetings with FDA. Prepares internal functional teams for these interactions to secure successful meeting outcomes. Coordinates preparation, authors, and finalizes meeting materials to include meeting requests, briefing books and meeting minutes. Works with cross functional teams and various departments to include Marketing, Medical Affairs, Regulatory Affairs, Supply Chain & Technical Operations, Pharmaceutical Technology, Quality Assurance and others where applicable. Identifies areas for process /procedure improvements and works on improvement implementation. Provides training on evolving regulations. BUSINESS TRAVEL Approximately 20% EDUCATION A Bachelor`s degree required in a relevant life science. A Master`s degree in Life Sciences or Ph. D preferred. BASIC REQUIREMENTS 8 years in pharmaceutical/biopharmaceutical industry experience. Focus on monoclonal antibodies and monoclonal antibody drug conjugates is a plus. 6 years direct CMC regulatory experience working with drug applications. Hands - on experience in authoring complex technical documents such as manufacturing/analytical method transfers, comparability protocols, NDA/BLA M3 sections, and life cycle management. A proven record of supplemental NDA/BLA submissions and NDA/BLA Annual Report submissions. The candidate should be detail-oriented, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment. Prior employment with FDA is preferred. Competencies: Extensive knowledge of US and ICH-CMC regulatory requirements for pharmaceutical and biological drugs. Ability to apply knowledge both strategically and operationally to marketed drug products to resolve regulatory issues. Must have a thorough knowledge and extensive successful experience with Technology Transfers, Established Conditions, Comparability Studies, Risk Assessment Studies, Stability Studies, and post approval change management. Expertise using Track Wise, eQMS and Veeva experience is a plus. Number of Direct Reports: Not applicable for this role. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.