Director, Global Regulatory Affairs (GRL)
Company: Daiichi Sankyo, Inc.
Location: Atlanta
Posted on: April 28, 2024
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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 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
Responsible for leading and developing global regulatory strategy
for assigned development projects. Represents Daiichi Sankyo's
regulatory group in internal and external development project
meetings. Conduct completeness, scientific accuracy, and ease of
review of the submissions. Provides guidance to peers and
cross-functional team members regarding strategic regulatory
issues. Develops timeline and strategic input with feedback from
the regional strategists in terms of HA meetings globally.
Responsible for representing GRA in the GPT (Global Project Team)
as well representing the project team in other DSI governance
process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical &
pre-clinical groups, Regulatory CM&C and other appropriate
group within the company as needed.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)
Experience Qualifications:
Travel
Ability to travel up to 30% 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.
Keywords: Daiichi Sankyo, Inc., Johns Creek , Director, Global Regulatory Affairs (GRL), Executive , Atlanta, Georgia
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