What are the responsibilities and job description for the Manager, Regulatory Affairs- CMC position at Daiichi Sankyo US?
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
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
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.
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
Salary : $127,280