Manager Regulatory Affairs CMC in Basking Ridge, New Jersey at DSI

Date Posted: 1/9/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

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, 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. Additionally, this position interacts with the clinical study teams and the Clinical Supplies Organization. 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.

  • 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.
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

  • B.S. in a scientific discipline, M.S. in a scientific discipline preferred
  • 5-8 years pharmaceutical industry experience with 2+ years direct CMC regulatory experience
Ability to travel up to 5%

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.