Associate Director Regulatory Affairs Labeling
Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: June 19, 2022
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Job Description:
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 15,000 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.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 15,000 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.
SummaryThis position serves as the 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). This position may serve as an
ad hoc member of Global Project Team (GPT) to address labeling
issues for late stage projects. This position manages multiple
assigned projects of increased complexity including post marketing
projects and those involving 3rd party development. This position
partners with GRLs and Clinical Safety Pharmacovigilance (CSPV)
leads in the maintenance of Company Core Data Sheets (CCDS) for
assigned products. This position drives/leads the maintenance of
global labeling and associated documents (including cartons and
external packaging in the US) for assigned Daiichi Sankyo products.
This position ensures that draft labeling complies with all
applicable regulations and guidelines and with Company Core Data
Sheets and manages deviations. This position interacts across the
RA function globally and interacts across functional as well as
regional areas. This position often works with ambiguity and
complex problems, focusing on strategic and operational
decisions.
Responsibilities
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)
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.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.
Keywords: Daiichi Sankyo, Inc., Newark , Associate Director Regulatory Affairs Labeling, Executive , Basking Ridge, New Jersey
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