Associate Director, US Regulatory Affairs Strategy NJ

7 days ago

new jersey, 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.

  • Director - Regulatory Affairs

    1 month ago

    new jersey, United States Apple & Associates Full time

    Position: Director - Regulatory Affairs  Role Summary:  Lead regulatory strategy and submissions.Collaborate with R&D, Technical Ops, Clin Dev, etc. to advance the company’s drug portfolio in order to ensure commercial success.  Responsibilities:- Guide development programs to meet both US and global regulatory standards.- Provide strategic...

  • Director - Regulatory Affairs

    2 weeks ago

    New Jersey, United States Tri-S Recruiters Full time

    Position: Director - Regulatory Affairs  Role Summary:  Lead regulatory strategy and submissions.Collaborate with R&D, Technical Ops, Clin Dev, etc. to advance the company’s drug portfolio in order to ensure commercial success.  Responsibilities:- Guide development programs to meet both US and global regulatory standards.- Provide strategic...

  • Director, US Regulatory Affairs Strategy NJ

    7 days ago

    new jersey, 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...

  • Senior Director, US Regulatory Affairs Alliance Team Lead NJ

    7 days ago

    new jersey, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 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 125 years of scientific expertise and a...

  • Daiichi Sankyo, Inc. | Associate Director, US Regulatory Affairs Strategy NJ

    1 week ago

    new jersey, 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...

  • Director Global Regulatory Affairs NJ

    7 days ago

    new jersey, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 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 125 years of scientific expertise and a...

  • Regulatory Affairs Director

    1 month ago

    new jersey, United States Gables Search Group Full time

    Position: Regulatory Affairs DirectorSummary:Lead the development of regulatory strategies and submissions.Collaborate with various departments such as R&D, Technical Operations, Clinical Development, etc. to advance the company’s drug portfolio and ensure its commercial success.Responsibilities:– Provide guidance for development programs in order to...

  • Regulatory Affairs Director

    2 weeks ago

    New Jersey, United States Gables Search Group Full time

    Position: Regulatory Affairs DirectorSummary:Lead the development of regulatory strategies and submissions.Collaborate with various departments such as R&D, Technical Operations, Clinical Development, etc. to advance the company’s drug portfolio and ensure its commercial success.Responsibilities:– Provide guidance for development programs in order to...

  • Daiichi Sankyo, Inc. | Senior Director, US Regulatory Affairs Alliance Team Lead NJ

    1 week ago

    new jersey, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 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 125 years of scientific expertise and a...

  • Daiichi Sankyo, Inc. | Director, US Regulatory Affairs Strategy NJ

    1 week ago

    new jersey, 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...

  • Senior Director of Regulatory Affairs

    6 days ago

    New York, United States Tandym Group Full time

    A leading healthcare organization in New York City is seeking a Senior Director of Regulatory Affairs to join their team. This key leadership role offers the opportunity to oversee a team of regulatory professionals while managing and interpreting regulatory requirements across the organization's portfolio, ensuring compliance and alignment with federal,...

  • Director of Regulatory Affairs

    1 month ago

    new york city, United States Arevna Full time

    Director of Regulatory Affairs and Compliance - Women’s HealthLocation: New JerseyWe’re seeking an experienced Director of Regulatory Affairs and Compliance to join a leading women’s health-focused organization based in New Jersey. In this role, you’ll drive regulatory strategies and compliance initiatives to support FDA approvals and maintain...

  • Daiichi Sankyo, Inc. | Director Global Regulatory Affairs NJ

    1 week ago

    new jersey, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 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 125 years of scientific expertise and a...

  • Senior Director of Regulatory Affairs

    1 week ago

    New York, United States MetroPlus Full time

    Empower. Unite. Care.The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.MetroPlusHealth is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit,...

  • Senior Director of Regulatory Affairs

    2 weeks ago

    New York, United States MetroPlus Full time

    Empower. Unite. Care.MetroPlusHealth is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit, work with us. You can come to work being proud of what you do every day.About NYC Health + HospitalsMetroPlusHealth provides the highest...

  • Regulatory Affairs Leader

    5 days ago

    New Bedford, Massachusetts, United States Lifelancer Full time

    Join Lifelancer, a pioneering talent-hiring platform in Life Sciences and IT. We are seeking an experienced Senior Manager/Associate Director to spearhead regulatory affairs for our clients.Salary: $120,000 - $180,000 per year, depending on qualifications and experience.About the RoleThis is a challenging opportunity to lead global regulatory strategies for...

  • Regulatory Affairs Intern NJ

    7 days ago

    new jersey, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 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 125 years of scientific expertise and a...

  • Senior Director of Regulatory Affairs

    3 months ago

    New York, United States MetroPlusHealth Full time

    Job DescriptionJob DescriptionEmpower. Unite. Care.MetroPlusHealth is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit, work with us. You can come to work being proud of what you do every day.About NYC Health +...

  • Senior Director of Regulatory Affairs

    3 months ago

    New York, United States MetroPlusHealth Full time

    Job DescriptionJob DescriptionEmpower. Unite. Care.MetroPlusHealth is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit, work with us. You can come to work being proud of what you do every day.About NYC Health +...

  • Medical Director

    2 weeks ago

    Jersey City, New Jersey, United States Lifelancer Full time

    About the RoleWe are seeking an experienced Medical Director - Regulatory Affairs and Compliance to join our Clinical Development Team working remotely in the US.Job OverviewThe Medical Director, Drug Safety Pharmacovigilance will be responsible for providing safety strategy, expertise, and guidance to the clinical development and project team for assigned...