Director, US Regulatory Affairs Strategy

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 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 This role offers the opportunity to substantially contribute to the mission of Daiichi Sankyo in leveraging our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. This role will work on one of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company’s growth, thereby accomplishing corporate goals. Responsibilities: Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings. Serve as the primary contact with FDA and liaise, negotiate and orchestrate meetings and teleconferences with FDA Lead and prepare FDA submissions, including but not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications. Participate in global project team meetings (development and/or marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities. Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. May serve as the single regulatory representative on study teams. Review and interpret regulatory guidelines. C ontinuing Education: Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. 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 required. Advanced degree (e.g., Masters, PharmD., Ph.D., MD, JD) preferred. Experience Qualifications: 10 or More Years in the pharmaceutical industry required. 8 or More Years in regulatory affairs Experience in providing regulatory strategic input into the drug development process with thorough knowledge of the IND and NDA/BLA processes. Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge of regulations, such as ICH is desirable. (s)NDA/BLA filing to FDA considered a plus. Competencies: Excellent oral and written communication skills, strong interpersonal skills; ability to work in a team environment; can work in high stress and deadline driven environment. Energetic, self-motivated and multi-task-oriented person. Proactive, disciplined, organized and detail oriented. Attention to detail is required. Demonstrates ability to think logically and objectively when identifying significant problems and opportunities. Travel: Ability to travel up to 30% In-house office position that may require occasional travel (global). 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.