Global Regulatory Affairs Leader
1 week ago
About Daiichi Sankyo
Daiichi Sankyo Group is a pharmaceutical leader with over 125 years of scientific expertise and a presence in more than 20 countries. We are dedicated to creating innovative therapies that improve standards of care for patients globally.
Our company's vision is to become a global pharma innovator with a competitive advantage in oncology, driven by our robust pipeline of promising new medicines. In addition to our strong portfolio of cardiovascular disease treatments, we are focused on providing novel therapies in oncology, rare diseases, and immune disorders.
Job Description:
We are seeking an experienced Senior Director Global Regulatory Affairs Strategy to join our team in Oncology Regulatory Strategy. This role will be responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology across various regions.
The successful candidate will have 10+ years of experience in the pharmaceutical industry, with at least 7 years in direct regulatory affairs, including experience in regulatory submissions in Oncology. A Bachelor's Degree is required, with an advanced degree preferred. Managerial experience and travel ability (up to 20%) are also necessary.
Responsibilities:
- Lead a multidisciplinary Global Regulatory Team to develop global regulatory strategies and plans for assigned projects. Gain endorsement from the Global Project Team and represent Global Regulatory Affairs on governance processes.
- Represent Daiichi Sankyo's regulatory group in internal and external development project meetings. Provide guidance to peers and cross-functional team members on strategic regulatory issues.
- Interface with clinical and pre-clinical groups, review and interpret regulatory guidelines, and participate on internal and external panels related to Health Authority initiatives.
Estimated Salary Range:$150,000 - $180,000 per year
Benefits:
- Comprehensive health insurance
- Retirement plan
- Generous paid time off
About Daiichi Sankyo, Inc.
We are an equal opportunity employer and welcome applicants from diverse backgrounds. Daiichi Sankyo, Inc. is committed to creating a workplace that values diversity, equity, and inclusion.
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