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.
Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.
Summary
This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on T-DXd and Dato-DXd, which are subject to an Alliance with AstraZeneca. This role will work on one of our cutting-edge assets within the alliance 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; meet aggressive deadlines to ensure that FDA receives 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.
The role will be accountable for coordinating, mentoring, and providing guidance to direct reports (US RA strategists) across the alliance products to produce robust, innovative and cohesive regulatory strategies/plans that take into consideration the past learnings within Daiichi Sankyo on the DXd-ADCs and the opportunities for synergies between the products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the assets. This role will be accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US RPMs assigned to alliance assets for operational matters.
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%. 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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