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Genmab A/S
Princeton, NJ, United States
At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and roote
Job Source: Genmab A/SGenmab A/S
Princeton, NJ, United States
The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at [email protected] . Director, Regulatory Affairs Strategy page is loaded Director, Regulatory Affairs Strategy Apply locations Princeton, NJ time type Full time
Job Source: Genmab A/SDaiichi Sankyo Company, Limited
, NJ, United States
Director, US Regulatory Affairs Strategy page is loaded Director, US Regulatory Affairs Strategy Apply remote type Hybrid Work Arrangement locations Basking Ridge, NJ time type Full time posted on Posted 2 Days Ago job requisition id R2533 Join a Legacy of Innovation 110 Years and Count
Job Source: Daiichi Sankyo Company, LimitedSun Pharma
Princeton Junction, NJ, United States
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration
Job Source: Sun PharmaSun Pharma
Princeton, NJ, United States
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration
Job Source: Sun PharmaDaiichi Sankyo Company, Limited
, NJ, United States
Associate Director, US Regulatory Affairs Strategy page is loaded Associate Director, US Regulatory Affairs Strategy Apply remote type Hybrid Work Arrangement locations Basking Ridge, NJ Remote by Design Home Office time type Full time posted on Posted 2 Days Ago job requisition id R3352 Join a Legacy
Job Source: Daiichi Sankyo Company, LimitedTaiho Oncology, Inc.
Princeton, NJ, United States
Associate Director, Regulatory Affairs Strategy Pleasanton, CA, USA ● Princeton, NJ, USA Req #374 Thursday, May 30, 2024 Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we al
Job Source: Taiho Oncology, Inc.Daiichi Sankyo
, 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 an
Job Source: Daiichi Sankyo, NJ, United States
Meet's partenered with a global pharmaceutical manufacturing company on an exciting new search for a Director, US Regulatory Strategy!
You'll be responsible for creating and implementing regulatory strategies, directing and implementing the preparation of US Regulatory submissions, meeting deadlines for regulatory agencies, shortening the review process, and receiving successful approval of pharmaceutical applications.
Responsibilities :
Develop and implement US regulatory strategy.
Act as the primary point of contact with the FDA and plan and lead meetings.
Lead and prepare FDA submissions.
Participate in glab project team meetings to provide regulatory support and guidance.
May act as the single regulatory representative.
Review and interpret regulatory guidelines.
Qualifications :
Bachelor's degree required. Masters, PharmD, PhD, MD, or JD preferred
10+ years in the pharmaceutical industry required.
8+ years in regulatory affairs.
Experience providing regulatory strategy for the drug development process.
Interpret and understand US regulations governing the pharmaceutical industry.
Ability to travel up to 30%
If you're interested in hearing more about this opportunity please apply or send your resume to [email protected]
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Email Alert for Director, US Regulatory Strategy jobs in , NJ, United States
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