- Gilead Sciences, Inc. (Washington, DC)
- …Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and ... regulatory expectations. Champion regulatory innovation and novel approaches to accelerate development and approval timelines. Provide guidance to PDM Teams and… more
- J&J Family of Companies (Irvine, CA)
- …related medical device regulatory _highly desired_ . + Working knowledge of US FDA & EU MDR regulatory requirements & processes **required** . + A ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Sarasota, FL)
- …applicable regulatory requirements. Job Description: + Develop, lead, and execute regulatory strategies to ensure compliance with USDA, FDA , other global, ... Hiring Company: Delicatessen Services Co., LLC Overview:The Director of Regulatory Affairs provides strategic leadership and oversight for all food safety … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …relevant experience. + BA/BS with 10+ years' relevant experience. + Significant regulatory , quality , compliance or related experience in the biopharma industry. ... Other Requirements** + In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory requirements and… more
- Sumitomo Pharma (Lincoln, NE)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global ... Regulatory Affairs (GRA) team based in the US. He/She...provides possible solutions and mitigation strategy + Ensures the quality and content of all submissions to Health Authorities… more
- Parexel (Providence, RI)
- …Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory documentation for FDA , EMA, and Health Canada (IND, NDA, DMF) * ... opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …hospital pharmacist.** Experience in medication safety, compliance, drug diversion and/or regulatory . **Be inspired. Be rewarded. Belong. At Emory Healthcare.** At ... And more! **Description** We are seeking an experienced pharmacist to oversee our regulatory and compliance program as it relates to federal and state requirements… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …pharmacology/pharmacokinetics/immunology is preferable. Strong knowledge of major industrialized country regulatory processes and considerations, FDA , EMA, and ... service to R&D and systems development in the four domains of Regulatory , Chemistry Manufacturing and Controls (CMC), and Global Health Integrated Development… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …and services in more than 110 countries and regions. **Summary:** The Regulatory Affairs Surveillance Specialist will determine and execute actions necessary BLA ... Licenses supplements and other regulatory submissions to ensure that Grifols Plasma Operations is...to or including the US Food and Drug Administration ( FDA ), Clinical Laboratory Improvement Amendments (CLIA), Plasma Protein Therapeutics… more
- Stryker (Las Vegas, NV)
- …among others. **Key Areas of Responsibility:** + Ensure divisional achievement of quality , regulatory , and compliance targets + Direct activities to ensure ... desired **Knowledge / Competencies:** + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA , and International requirements +… more