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.
Summary
The Senior Director, Global Regulatory Operations is responsible for the management and oversight of the Dossier Planning, Document Excellence and Submissions Publishing groups in China, Europe, Japan and the US. This role ensures that health authority dossiers meet the quality and timeliness requirements within Daiichi Sankyo and meet global regulatory agency requirements and standards. The Senior Director is also responsible for the creation and improvement of the processes, procedures and standards for the submission and maintenance of original INDs/CTAs, original and supplemental NDAs/BLAs/MAAs, CMC supplements, lifecycle maintenance submission, and periodic reporting submissions.
The Senior Director collaborates with his/her counterparts cross-functionally to ensure that timelines for the review and QC of documents required for submissions are jointly developed to foster a seamless flow of documents in order to meet submission timelines. The Senior Director of RO also liaises with RO counterparts and senior leaders in China, Europe, Japan and the US in developing both strategic and tactical plans for delivering submissions including the harmonization of processes and systems for the efficient compilation and publishing of documents and data in any of the three regions (U.S., EU and Japan). This role collaborates with the Regulatory Information Management lead to develop the system, tool and data roadmap for the Regulatory systems used in the end-to-end submission process. The Senior Director RO is an active contributor to the Regulatory Management Operations Leadership Team.
Responsibilities
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)
Experience Qualifications
Travel
Ability to travel up to 20%. May require occasional global 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.
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