- Rhythm Pharmaceuticals (Boston, MA)
- …+ BS or graduate degree in life sciences preferred + 8+ years of Regulatory Affairs experience in drug development and product registration activities within the ... to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development… more
- Xcelerate Solutions (Frederick, MD)
- …trend knowledge points and risks through the medical portfolio + Track and trend FDA regulatory intelligence + Assist with full lifecycle project management and ... Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking...program office operations. + Tailor DoD acquisition policies to drug development and biosurveillance activities. + Support MRAS leadership… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Regulatory matters + Maintain good relationships with oncology and malignant hematology regulatory reviewers at FDA , EMA, and other key Health Authorities ... The role leads a group within Regeneron's Regulatory Affairs organization that provides guidance to Research,...strategies for the development of Oncology & Malignant Hematology drug products to ensure all corporate objectives are met… more
- Abbott (St. Paul, MN)
- …and other regulatory requirements. . Complies with US Food and Drug Administration ( FDA ) regulations, international regulations and other regulatory ... with diabetes from routine fingersticks. **The Opportunity** We are currently hiring a Regulatory Affairs Operations Specialist I to work on-site at our St. Paul or… more
- Abbott (Santa Clara, CA)
- … regulatory requirements to development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to ... products for treatment of vascular disease. Our extensive portfolio includes drug -eluting stents, bare metal stents, guide wires, balloon dilatation catheters,… more
- Stryker (Redmond, WA)
- We are currently seeking a **Senior Regulatory Affairs Specialist** to join our **Medical** **Division** to be based **Hybrid** Monday through Wednesday in ... **What you will do** As part of the Medical Regulatory Affairs team, you will work with the team...+ Minimum of 2 years of experience in an FDA or highly regulated industry + Minimum of 1… more
- Jabil (West Chester, PA)
- …foster vibrant and diverse communities around the globe. Are you experienced in Regulatory Compliance? Jabil is seeking a qualified Regulatory Compliance Manager ... to work in West Chester, PA. As the Regulatory Compliance Manager, you will manage all Regulatory...audits: eg Notified Body, Ministry of Health country inspections, FDA , J&J Corporate Audits for site. + Audit preparation… more
- Bausch Health (Bothell, WA)
- …of regulatory submissions for product change updates, extensions, or modifications to regulatory bodies (eg, FDA , EMA). + Ensure that regulatory ... skills and values drive our collective progress and impact. The Manager Regulatory Affairs provides direct support to Solta operations for their globally distributed… more
- Bausch Health (Bothell, WA)
- …meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as US FDA product clearance, Health Canada registration, ... skills and values drive our collective progress and impact. The Manager, Regulatory Affairs will be responsible for: + Responsible for developing and implementing… more
- Sanofi Group (Morristown, NJ)
- …on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
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