- ThermoFisher Scientific (Frederick, MD)
- …experience strongly preferred. **Knowledge, Skills, Abilities:** + Extensive knowledge of regulatory requirements, including those from the FDA, Health Canada, ... for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs, you will play a crucial role in...team, and/or individual performance results in accordance with company policy . We offer a comprehensive Total Rewards package that… more
- BeOne Medicines (San Mateo, CA)
- …development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends. Understands scientific and ... experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading cross-functional regulatory teams, developing and… more
- Takeda Pharmaceuticals (Boston, MA)
- …with Health Authorities. + Ensures labeling content conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages the ... to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for...new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and… more
- Oracle (St. Paul, MN)
- …occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the ... To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws,… more
- Virginia Mason Franciscan Health (Tacoma, WA)
- **Job Summary and Responsibilities** The Regulatory Compliance Program Manager provides operational support and overall coordination for the strategic implementation ... standards established through state and federal regulations. Facilitates on-going regulatory compliance activities through extensive rounding on clinical and… more
- Highmark Health (Pittsburgh, PA)
- **Company :** Highmark Health **Job Description :** **JOB SUMMARY** This role is hybrid (T/W/Th) in our Pittsburgh Office** This job investigates factual situations ... upon knowledge of federal, state and other applicable law and the regulatory environment in which the Corporation and its affiliates ("Corporation") function. A… more
- Emory Healthcare/Emory University (Atlanta, GA)
- … Regulatory Affairs is an operational leader responsible for managing day-to-day regulatory activities and readiness across the health system. The Corporate ... 4. Assists sites interpret and operationalize requirements in alignment with health system policies ** Policy , Procedure and Program Implementation:** 1.… more
- Teva Pharmaceuticals (West Chester, PA)
- …strategic regulatory planning, preparation, and execution of meetings with health authorities (eg, FDA, EMA). * Point-of-contact for interfacing with health ... team. * Lead facilitator for the timely submission and approval of regulatory applications and coordinates appropriate responses to health authorities to… more
- The Estee Lauder Companies (New York, NY)
- …NIOD, and BALMAIN Beauty. **Description** The Associate Counsel, Global Legal Marketing & Regulatory is responsible for advising on legal and regulatory issues ... and commercialization. This role supports cross-functional teams - including regulatory affairs, marketing, product innovation, and quality assurance - by… more
- Dana-Farber Cancer Institute (Boston, MA)
- …training and implementation of new or revised regulation, guidance and or local policy . + Present regulatory status for disease group portfolio at applicable ... The ** Regulatory Coordinators (RC)** works under the direction of...of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct… more