Associate Director, US Regulatory Affairs Strategy

1 week ago

Bernards NJ, United States Daiichi Sankyo, Inc. Full time

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 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 for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the full discussion for archiving. Serve as the primary contact with FDA.
  • Lead and prepare FDA submissions, including but not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications.
  • Participate in global product team meetings (development and 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.
  • Review and interpret regulatory guidelines
  • Continuing 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 in chemistry, biology or other related scientific discipline required
  • Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred

Experience Qualifications

  • 4 or More Years in the pharmaceutical industry preferred
  • 1 or More Years in regulatory affairs required
  • Experience in (s)NDA/BLA filing to FDA preferred

Travel

Ability to travel up to 20%. 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.

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