Senior Director Global Regulatory Affairs Strategy

4 days ago


Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

Job Summary:

Daiichi Sankyo, Inc. is seeking a Senior Director Global Regulatory Affairs Strategy to lead the development of global regulatory strategies and plans for assigned global projects. The ideal candidate will have 10+ years of experience in the pharmaceutical industry, with 7+ years of direct regulatory affairs experience, including experience in regulatory submissions in Oncology.

Key Responsibilities:

  • Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects.
  • Gain endorsement from the Global Project Team (GPT) for these plans, ensuring appropriateness throughout the product's lifecycle and across different indications.
  • Represent Global Regulatory Affairs on the GPT, Daiichi Sankyo governance processes, and on Joint Alliances.
  • Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area strategy, corporate goals, and regional regulatory requirements/precedence.
  • Represent Daiichi Sankyo's regulatory group in internal and external development project meetings.
  • Provide guidance to peers and cross-functional team members regarding strategic regulatory issues.
  • Develop timeline and strategic input with feedback from the regional strategists in terms of Health Authority meetings globally.
  • Provide leadership and set direction, acting as a key decision-maker and/or arbitrator on global projects.

Qualifications:

  • Bachelor's Degree required.
  • Advanced degree (e.g., Masters, Pharm.D., Ph.D.) in a scientific discipline preferred.
  • 10 or More Years Experience in the pharmaceutical industry.
  • 7 or More Years with direct regulatory affairs experience, including experience in regulatory submissions in Oncology.
  • Managerial experience.
  • Experience with ex-US regulatory authorities.
  • Travel - Ability to travel up to 20%.

About Daiichi Sankyo, Inc.:

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.

We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools, and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensure that each employee's unique abilities are valued and utilized.



  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Global Regulatory Affairs Strategy DirectorDaiichi Sankyo Group is a leading pharmaceutical company dedicated to creating and supplying innovative therapies to improve standards of care and address unmet medical needs globally. As a Global Regulatory Affairs Strategy Director, you will play a crucial role in shaping the company's regulatory strategy for...


  • Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job OverviewThis is a senior leadership position responsible for providing strategic direction and oversight for global regulatory submissions in Oncology. The successful candidate will ensure alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives.Key ResponsibilitiesThis position will...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Global Regulatory Affairs Strategy LeadDaiichi Sankyo Group is dedicated to creating and supplying innovative pharmaceutical therapies to improve standards of care and address diverse, unmet medical needs globally. As a key member of our team, you will be responsible for providing oversight and formulation of strategy for global regulatory submissions in...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job SummaryThis position is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other regions.The successful candidate will ensure alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives.This role...


  • Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job DetailsTransforming Healthcare through Innovative Regulatory StrategiesDaiichi Sankyo Group is dedicated to creating and supplying innovative pharmaceutical therapies to improve healthcare standards and address unmet medical needs globally. With a rich legacy of scientific expertise and a presence in over 20 countries, Daiichi Sankyo and its 16,000...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Role SummaryThis position is responsible for providing strategic oversight and formulation of regulatory strategies for global submissions in Oncology across the US, EU, Japan, China, and other regions. The role ensures alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives.Key...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Unlock Your Potential in Regulatory AffairsDaiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to creating innovative therapies that improve patient outcomes. We are seeking a highly skilled Director of Regulatory Affairs Strategy to join our team.About the RoleThis is an exciting opportunity to contribute to the development of our regulatory...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job SummaryDaiichi Sankyo, Inc. is seeking a highly skilled Global Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key ResponsibilitiesLiaise with FDA and other regulatory agencies to ensure timely and quality...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Join Our Team at Daiichi Sankyo, Inc.Company OverviewDaiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to improving standards of care and addressing unmet medical needs globally. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to delivering novel therapies in oncology and other research...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Regulatory Affairs DirectorDaiichi Sankyo, Inc. is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing US regulatory strategies for assigned projects. Your expertise in FDA regulations and guidelines will be essential in ensuring timely and...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Regulatory Affairs Strategy LeadDaiichi Sankyo, Inc. is a global pharmaceutical company dedicated to creating innovative therapies to improve patient outcomes. We are seeking a highly skilled Regulatory Affairs Strategy Lead to join our team.This role will be responsible for developing and implementing effective regulatory strategies to support the...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Unlock Your Potential in Regulatory AffairsDaiichi Sankyo, Inc. is a global pharmaceutical innovator with a rich legacy of innovation and a robust pipeline of promising new medicines. We are seeking a highly skilled Regulatory Affairs Director to join our team and contribute to our mission of delivering innovative treatments for patients with cancer.Key...


  • Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job SummaryThis role offers the opportunity to contribute to the mission of Daiichi Sankyo in leveraging innovative science to create meaningful treatments for patients with cancer. The Director of Regulatory Affairs will work on one of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA. This role will create and implement...


  • Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job SummaryThis is an exciting opportunity to contribute to the mission of Daiichi Sankyo in leveraging innovative science to create meaningful treatments for patients with cancer. As a key member of the regulatory affairs team, you will play a critical role in developing and implementing effective regulatory strategies to deliver on efficient and robust...


  • Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job Title: Regulatory Affairs DirectorThe Director of Regulatory Affairs will provide leadership on global regulatory activities for assigned products. Responsibilities will focus on Clinical Regulatory filings and provide regulatory leadership on project teams in this area. We are a hands-on culture, so responsibilities will include support to some clinical...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job Summary:Daiichi Sankyo, Inc. is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Liaise with FDA to ensure timely and quality submissionsPrepare and publish regulatory documents...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job SummaryWe are seeking an experienced Associate Director to lead our Global Regulatory Affairs Labeling team. The successful candidate will have a strong background in pharmaceutical industry experience, with a focus on regulatory affairs and labeling.Key ResponsibilitiesProvide strategic and operational leadership on product labeling in collaboration...


  • Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    About Daiichi Sankyo, Inc.Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to improving the lives of patients worldwide. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to delivering high-quality products that meet the evolving needs of healthcare professionals and patients.Job SummaryWe...


  • Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job SummaryThis role offers the opportunity to contribute to the mission of Daiichi Sankyo in leveraging innovative science and creating meaningful treatments for patients with cancer. The successful candidate will develop and implement effective regulatory strategies to deliver on efficient and robust development plans. They will direct, coordinate and...


  • Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job SummaryThis role will work on one of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA. 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...