What are the responsibilities and job description for the Manager, RACMC position at Daiichi Sankyo, Inc.?
Join a Legacy of Innovation 125 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 18,000 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.
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 Contract Sales Organization (CSO). 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 guidance's and their application during the development process.
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)
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
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.
