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Form of workJoin 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 16,000 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.
Summary
The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small molecule and biological drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. 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 biologics to meet US, International Conference on Harmonization (ICH), and other applicable regulations. This includes preparation, review, and approval of CMC documentation for BLA Supplements (PAS, CBE-0, CBE-30), 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 biologics 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, and other functional areas to secure approval of CMC changes and assess regulatory implications.
- Participates in meetings with FDA. Prepares internal functional teams for these interactions to build strong relationships with FDA and 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 and others where applicable. Identifies areas for process /procedure improvements and works on improvement implementation. Provides training on evolving regulations.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Bachelor's Degree Life science required and
- Master's Degree Life science preferred and
- PhD Life science preferred
Experience Qualifications
- 7 or More Years 8+ years in pharmaceutical/biopharmaceutical industry experience with a focus on small molecules and monoclonal antibodies/monoclonal antibody drug conjugates. Hands - on experience in authoring CTD Modules 2 and 3 documents for small molecules and biologics. A proven record of supplemental NDA/BLA submissions and NDA/BLA Annual Reports. The candidate should be detail-oriented, self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment. required and
- 6+ years of direct regulatory experience working with NDAs/BLAs. preferred
- 4+ years of prior employment with FDA preferred.
Travel
Ability to travel up to 10%. Domestic or international travel
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.
