53 applicants
Daiichi Sankyo, Inc. · 2 days ago
Associate Director, Labeling
United States
Full-time
Hybrid
Director
7+ years exp
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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. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS). Independently leads cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as point of contact for cross-functional teams on RA 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. Follows internal processes for record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.
Establishes Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.
Department Coordination: Builds cross-functional and cross-regional relationships.
Qualification
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Required
Bachelor's Degree preferably in a scientific discipline required
7 or More Years pharmaceutical industry experience required
4 or More Years of direct regulatory affairs experience, including US labeling experience
Preferred
advanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferred
Experience with ex-US labeling (outside the US) preferred
Ability to travel up to 10%
Occasional travel
Company
Daiichi Sankyo, Inc.
At Daiichi Sankyo, we create essential medicine for longer, better lives.
10,001+ employees
H1B Sponsorship
Daiichi Sankyo, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (14)
2022 (13)
2021 (7)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Ken Keller
Chairman of the Board, President and CEO and Head of the Global Oncology Business Unit
Christopher Geloso
Senior Region Business Director - ADC Oncology at Daiichi Sankyo, Inc.
Recent News
Endpoints News
2024-05-29
2024-05-28
Google Patent
2024-04-13
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