Taiho Oncology
Associate Director, Regulatory Affairs Strategy (Project Management)
Looking
for a chance to make a real difference in the oncology space? Taiho Oncology is
on a mission: to improve the lives of cancer patients, their families, and
caregivers. Our “People first” approach means we also value our employees, who
work relentlessly to help us execute our mission. Taiho's success is founded on
ensuring we always act with accountability, collaboration, and trust. By
following these guiding principles, we earn and maintain the confidence of our patients,
our partners, and each other. Together, we're working to discover and develop
innovative cancer treatments that address unmet patient needs and apply the
science behind them in novel ways. As the field of cancer treatment evolves, we
evolve with it. Advanced technology, dedicated investigators, and incomparable
facilities: these vast resources empower us to redefine the way the world
treats cancer. It's our work, our passion, and our legacy. If the prospect of
being part of this sounds exciting, we invite you to join us.
Position Summary:
Under the direction of Senior Director, Regulatory Affairs strategy,
the incumbent independently prepares and directs global regulatory affairs
activities and provides regulatory guidance during drug development, approval
and post approval processes and commercialization, in coordination with both
the internal and external consultants and contractors in the oncology
therapeutic area. The incumbent initiates interactions and negotiations
directly with regulatory authorities during the drug development and approval
processes following an agreed upon plan. The incumbent conducts the regulatory
activities to ensure high quality, regulatory integrity and completeness of all
projects, supporting IND, NDA, MAA, IMPD and CTA submissions.
Responsibilities and Duties:
Educational Requirements:
Experience: