What are the responsibilities and job description for the Manager, Global Labeling 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 125 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. 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.
Summary
The Manager, Regulatory Affairs Labeling position will provide Regulatory support for global labeling projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product Labeling for FDA submission, complete electronic drug listing, track and archive affiliate labeling for global products and review proposed labeling from affiliates.
Responsibilities
- Provide Regulatory support in the development, revision, review, and approval of labeling content for submission to FDA, as well as any post marketing labeling changes. Review new labeling for accuracy and consistency with CCDS.
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Create/modify labeling in Structured Product Label (SPL) for FDA submission
Complete electronic drug listing for applicable drugs in accordance with federal requirements and guidance documents
Identify changes needed for FDA- approved labeling including updates to Reference Listed Drug, USP updates and updates for new Regulatory requirements -
Track global affiliate labeling for global products including timelines for submissions and approvals, and documentation for deviations and deferrals
Archive local affiliate labeling in central repository - Working with RA and RO representatives develop timelines for development of CCDS and USPI for new products
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Review proposed labeling from global affiliates for consistency with CCDS
Working with other functional representatives, develop draft responses to Regulatory Authority letters regarding labeling, both US and worldwide, as appropriate - Develop and maintain tools/lists that support labeling working teams, including LRCs (US) and CDS development teams (global)
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 required
- Master's Degree in Life Sciences preferred
Experience Qualifications
- Experience in the pharmaceutical industry
- 4 or More Years direct regulatory affairs experience
- 4 or More Years in the biopharmaceutical industry specifically RA Labeling preferred
- Working knowledge of laws, regulations and guidelines required
- Applied knowledge of FDA labeling requirements preferred
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.
