Hybrid Manager, Global Labeling bei Daiichi Sankyo
Daiichi Sankyo · Basking Ridge, NJ, Vereinigte Staaten Von Amerika · Hybrid
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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.
- 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.
- 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
- 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)
- Bachelor's Degree required
- Master's Degree in Life Sciences preferred
- 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
