Global Regulatory Affairs Expert: Strategic Leadership for Pharmaceutical Labeling
6 days ago
This position serves as a GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). The successful candidate will be responsible for managing multiple assigned projects of increased complexity, including post-marketing projects and those involving 3rd party development.
Key Responsibilities:- Acts as point of contact for cross-functional teams on global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.
- Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for assigned products. Manages US/EU and local country labeling deviations from CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.
- Conduct Label Review Committee Meetings: Prepares documents for review by labeling teams. Leads review processes and ensures appropriate governance for US, EU and Company Core documents as well as for the review of country labeling deviations.
- Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both content and format.
- Bachelor's Degree preferably in a scientific discipline required
- Advanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferred
- 7 or More Years pharmaceutical industry experience required
- 4 or More Years of direct regulatory affairs experience, including US labeling experience required
The estimated salary for this position is $120,000 - $180,000 per year, depending on experience and qualifications.
About Daiichi Sankyo, Inc.: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.
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