- GE HealthCare (Chicago, IL)
- …functions such as Engineering, Clinical, and Scientific, and submits premarket submissions to regulatory authorities such as FDA , EU, NMPA, PMDA, MFDS, CDSCO, ... **Job Description Summary** Provides regulatory strategy and direction to the business regarding...employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …strategic regulatory advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess regulatory impact of changes ... regulatory processes. Additional Responsibilities: + Maintain awareness of all regulatory activities regarding new and approved drug products. Stay current… more
- West Pharmaceutical Services (Exton, PA)
- …+ 3-5 years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience + Experience with US FDA regulations (Title 21CFR820), EU MDD ... Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746...of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug … more
- Integra LifeSciences (Plainsboro, NJ)
- …patient outcomes and set new standards of care. The **Internal Auditor, Regulatory Compliance** will have an in-depth understanding and knowledge of appropriate GMP ... on-going project support and governance, as assigned. + Provide support for regulatory inspections, input to responses and corrective action plans and ensure the… more
- Actalent (Grand Prairie, TX)
- …in Grand Prairie, Texas! Description/Job Duties: + Ensure lab practices align with FDA , Health Canada, and international regulatory standards + Maintain and ... USD Yearly Education: College degree required Experience: + 2-5 years experience in Regulatory Affairs + Over-the-Counter Drug , Cosmetic, and/or Food Industry … more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape the ... future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in… more
- Lilly (Indianapolis, IN)
- …the world. We are seeking a strategic and experienced Senior Director of Drug Supply Chain Security Act (DSCSA) Compliance & Quality to lead our enterprise-wide ... This role will be responsible for ensuring the integrity, traceability, and regulatory compliance of our pharmaceutical supply chain, while also driving continuous… more
- Merck (Rahway, NJ)
- …+ Deep and broad working knowledge of pharmaceutical vaccine/biologic/small molecule drug product and process development including regulatory submission and ... & Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug / vaccine - device enabled combination products to achieve safe and… more
- University of Colorado (Aurora, CO)
- …research coordinators, and clinical teams to ensure safe and efficient investigational drug management + Ensure compliance with FDA regulations, IND ... **Condition of Employment:** **Preferred Qualifications:** + Experience with investigational drug services, clinical research operations, or IRB/ regulatory … more
- Boehringer Ingelheim (Ridgefield, CT)
- …DNP, DO, Ph.D., Master's) preferred + Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification preferred **Associate Director Experience ... the global and US cross-functional teams. They will also provide US strategic regulatory guidance to facilitate efficient and compliant drug development and… more
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