- Regeneron Pharmaceuticals (Tarrytown, NY)
- This role resides in the Global Development area of Regulatory Affairs , Global Patient Safety and Development Quality (RA, GPS and DQ) and the Director of ... + Actively participate in operational optimization activities supporting the broader Regulatory Affairs , Global Patient Safety and Development Quality department… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- United Therapeutics (Eden Prairie, MN)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… more
- Bausch Health (Bridgewater, NJ)
- …CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy, to deliver high… more
- Bristol Myers Squibb (Brisbane, CA)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Takeda Pharmaceuticals (Boston, MA)
- …global vaccine programs in various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure ... CMC regulations and guidelines by applying interpersonal skills and expert regulatory CMC knowledge to identify, communicate, address, and overcome challenges that… more
- BeOne Medicines (Harrisburg, PA)
- **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual ... in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC-related regulatory submissions and… more
- CareOregon (Portland, OR)
- … Affairs Exemption Status Exempt Requisition # 24946 Direct Reports N/A Manager Title Director , Regulatory Affairs Pay & Benefits Estimated hiring range $ ... , programmatic and project related matters, collaborating closely with the Director and Regulatory Affairs Portfolio Manager to ensure smooth processes.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory PMs… more
- Novo Nordisk (Bloomington, IN)
- … liaison to clients and internal functional departments. Relationships Reports to: Associate Director , Regulatory Affairs Essential Functions + Review new ... Novo Nordisk and help us make what matters. The Position The Regulatory Affairs department is accountable for the direct management and guidance regarding the… more