130 applicants
Daiichi Sankyo, Inc. · 2 days ago
Director, Head of Global Dossier Planning
United States
Full-time
Remote
Director
7+ years exp
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Responsibilities
Provide oversight for all Global complex submissions (NDAs, INDs, BLAs, MAAs and supplements). Lead the Dossier planning team and act as an escalation point for direct reports when questions, issues, etc. are raised on dossier planning/submission topics.
Manages and develops internal talent ensuring a balance between internal resources and use of external vendors to ensure flexibility in the planning of global complex submissions. Mentor/coach and provide guidance to direct reports.
Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. Lead Dossier planning team meetings for major complex submissions and related activities.
Lead a cross-functional team within RD to explore submission process optimization. Develop standard processes and tools for submission planning activities.
Review and interpret regulatory guidelines.
Continuing Education: Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions.
Qualification
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Required
Bachelor's Degree in scientific, business or engineering discipline required
7 or More Years Pharmaceutical industry and Regulatory operations required
4 or More Years regulatory affairs including filing NDA and sNDA. BLA filing to FDA considered a plus.
Preferred
Master's Degree preferred
Ability to travel up to 20% In-house office position that may require occasional travel (global)
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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