Job Description
Manager, Regulatory Affairs- CMC Employer Daiichi Sankyo Location Basking Ridge - NJ Start date Jun 1, 2026 View more categories View less categories Discipline Regulatory , Regulatory Affairs , Science/R D , CMC Required Education Bachelors Degree Position Type Full time 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:
Manager, Regulatory Affairs- CMC Job Requisition ID:
1525 Posting Start Date:
6/1/26 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 This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the broader RA team. This position manages assigned developmental and post marketing projects with a high level of supervision. This position prepares content templates and supports the technical team in the preparation of submission documents (e.g., IND, BLA, IB, NDA, Amendments, Supplements, Briefing Books) for review by higher-level manager. This position demonstrates understanding of key regulatory guidances and their application during the development process. This position works with problems that are typically simple, straightforward and task driven. This position has a high level of supervision and is supportive in nature. Responsibilities Planning for Development and Post Marketing Projects:
Manages CMC development and post marketing projects. Execution of Strategy and Submissions:
Prepares content templates and supports the technical team in preparation of submission documents for review by higher-level manager. FDA Interactions:
Leads FDA interactions with high level of supervision. Regulatory Knowledge:
Demonstrates understanding of key US regulatory guidances and their application during the development process. Qualifications Education Qualifications Bachelor's Degree in a scientific discipline required Master's Degree in a scientific discipline preferred Experience Qualifications 5-8 years of pharmaceutical industry experience with 2+ years of direct or related CMC regulatory experience preferred Travel Requirements Ability to travel up to 5% 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$127,280.00 - USD$190,920.00 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
