Director, Global Regulatory Affairs (GRL) Employer Daiichi Sankyo Location Basking Ridge - NJ Start date Aug 19, 2026 View more categories View less categories Discipline Regulatory , Regulatory Affairs Required Education Bachelors Degree Position Type Consultant Hotbed Pharm Country , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job

Job Details Company Job Details Job Description Job Title:

Director, Global Regulatory Affairs (GRL)

Job Requisition ID:

2046

Posting Start Date:

8/18/26 At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Global Regulatory Lead (GRL) is responsible for leading and developing global regulatory strategy for assigned development projects. The GRL represents Daiichi Sankyo's regulatory group in internal and external development project meetings, provides guidance to peers and cross-functional team members regarding strategic regulatory issues, and develops overall regulatory strategy with input from respective regional strategists for global Health Authority interactions. The GRL is responsible for representing Global Regulatory Affairs on the Global Project Team (GPT), as well as in early- and late-stage governance meetings. The GRL interfaces with clinical and non-clinical groups, Regulatory CM&C, Biostatistics, Companion Diagnostics, Precision Medicine, and other appropriate functions within the company. Job Description Responsibilities Manages, directs, and drives the strategy for all regulatory activities associated with the registration and support of new and approved drug products. Responsible for ensuring aligned global regulatory strategy is endorsed by the Global Project Team and governance bodies. Serves as a leader of the Global Regulatory Team (GRT) and is responsible for strategic integration of regional strategies, including an understanding of CMC, supply chain and commercialization aspects to support Health Authority requirements. This includes review of key regulatory documents, e.g., protocols, briefing books, and health authority submission documents. Serves as the primary point of contact with Alliance Partners Joint-regulatory teams and Joint-GPT. Keeps current with latest Health Authority guidelines and provides regulatory advice to members within Regulatory, and other departments within the Company. Communicates with outside consultants (i.e. CROs, external partners) as needed. Qualifications Education Qualifications (from an accredited college or university) Bachelor's Degree preferably in a scientific discipline required Advanced degree (e.g., Masters, Pharm.

D., Ph.

D., MD, JD

) preferred

Experience Qualifications:

Broad and deep scientific and regulatory expertise in early- and late-stage development across modalities and therapeutic areas with focus on oncology Drug Discovery and Development knowledge across the R D continuum 7 or more years of relevant pharmaceutical experience including 5 years of experience in a Strategy role within Regulatory Affairs Hands on NDA/BLA submission experience in a major geographical region, including the US Demonstrated experience in global Health Authority negotiations Manages complexity of regulatory strategy across regions and has the knowledge to provide regulatory guidance based on understanding of global regulations Communicates and collaborates effectively and deals well with ambiguity Working knowledge of CMC and Companion Diagnostics Travel Requirements Ability to travel up to 20% of the time. 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.

Salary Range:

USD$193,040.00 - USD$289,560.00 Download Our Benefits Summary PDF Professionals Company 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 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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. For more information, please visit: www.daiichisankyo.com . Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com .

STOCK EXCHANGE

Tokyo Stock Exchange

STOCK SYMBOL

4568 Company info Website http://www.daiichisankyo.com/ Phone (908) 992-6400 Location 211 Mt. Airy Road Basking Ridge New Jersey 07920 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Director, QA for QC Cambridge, MA LATAM Government and Regulatory Affairs Manager - Mexico Mexico, MEX Senior Director, Head of Regulatory & Medical Writing Brisbane, California, United States