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BioSpace, Inc.
Basking Ridge, NJ, United States
Job Details Join a Legacy of Innovation 110 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 100 years of scientifi
Job Source: BioSpace, Inc.Daiichi Sankyo, Inc.
Basking Ridge, NJ, United States
Join a Legacy of Innovation 110 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 100 years of scientific expertise a
Job Source: Daiichi Sankyo, Inc.Daiichi Sankyo Inc.
Basking Ridge
**Join a Legacy of Innovation 110 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 100 years of scientific expertis
Job Source: Daiichi Sankyo Inc.Novartis Farmacéutica
East Hanover, NJ, United States
(Senior) Clinical Development Medical Director - Rheumatology Job ID 381169BR May 20, 2024 USA Summary As a Clinical Development Medical Director in our Immunology Development Unit you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.The Clinical Dev
Job Source: Novartis FarmacéuticaNovartis Farmacéutica
East Hanover, NJ, United States
(Senior) Clinical Development Medical Director - Rheumatology Job ID 381169BR May 20, 2024 USA Summary As a Clinical Development Medical Director in our Immunology Development Unit you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.The Clinical Dev
Job Source: Novartis FarmacéuticaSanofi Group
Bridgewater
**Job title: Global Regulatory Lead** + Location: Bridgewater, NJ or Cambridge, MA **About the job:** Our team is involved in developing regulatory product strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage of drug products. We are an innovative global healthcare company with one pur
Job Source: Sanofi GroupNovartis Group Companies
East Hanover, NJ, United States
Job Description Summary As a Clinical Development Medical Director in our Immunology Development Unit you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. The Clinical Development Medical Director (CDMD) is the clinical leader of defined program level ac
Job Source: Novartis Group CompaniesDaiichi Sankyo, Inc.
Basking Ridge, NJ, United States
Join a Legacy of Innovation 110 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 100 years of scientific expertise a
Job Source: Daiichi Sankyo, Inc.Basking Ridge, NJ, United States
Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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 Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and leading all planning activities for Daiichi Sankyo major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited to original NDA/BLA/MAA,IND/CTA, supplements, annual reports as well as the rapid and efficient turnaround of time-sensitive submissions. The Director of Dossier Planning will collaborate with other functional areas to ensure that timelines for the submissions are jointly developed to foster a seamless flow of documents in order to meet submission timelines.
The Director will develop the process, tools and systems needed to build a core dossier for global submissions, they will liase with Global RO counterparts and key internal stakeholders to develop strategic and tactical plans for harmonizing processes of Global Dossier planning capabilities in all regions. The Director of Dossier Planning will report to Head of Global Regulatory Operations and be an active participant on the Regulatory Operations Leadership Team.
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.
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 in scientific, business or engineering discipline required
Master's Degree preferred.
Experience Qualifications
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..
Travel Ability to travel up to 20% In-house office position that may require occasional travel (global)
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.
Email Alert for Director, Head of Global Dossier Planning - Regulatory Operations jobs in Basking Ridge, NJ, United States
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