- Mount Sinai Health System (New York, NY)
- …+ Prioritize resources and allocate tasks to ensure timelines and objectives are met. ** Regulatory Compliance and Quality Assurance:** + Ensure all trials ... 2 years managing investigator-initiated trials preferred. + Proven track record in regulatory compliance , project management, and team leadership. + Progressive… more
- Amgen (Washington, DC)
- …development, database lock, and regulatory submissions/ approvals). Reporting to the Quality Compliance Associate Director, you will oversee quality ... of regional expertise to ensure quality and compliance to local Regulations + Support Clinical ...** Regulatory Submission** and **Inspection Management** procedures. + ** Quality Oversight of Clinical Trials** , including… more
- Amgen (Thousand Oaks, CA)
- …teams including clinical operations, biostatistics, regulatory affairs, and quality to drive data integrity and compliance with global regulatory ... or directing the allocation of resources **Preferred Qualifications:** + Experience within clinical data management, regulatory compliance , and strategic… more
- Bausch + Lomb (Madison, WI)
- …reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance , regulatory intelligence and change ... US and/or Canada + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical...to product development teams and give guidance on potential regulatory compliance issues + Point of contact… more
- Fujifilm (Research Triangle Park, NC)
- …programs and harmonization across the organization + Oversees and coordinates regulatory activities for multiple projects, ensuring compliance throughout the ... regulatory successes to drive industry transformation + Participates in site Quality Leadership Teams (QLTs) and coordinate regulatory assignments + Navigates… more
- J&J Family of Companies (Irvine, CA)
- …of regulatory information to the product development, marketing, and clinical groups. + Performs Copy Review for internal and external facing documentation ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- J&J Family of Companies (Irvine, CA)
- …of regulatory information to the product development, marketing, and clinical groups. + Performs Copy Review for internal and external facing documentation ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- Sumitomo Pharma (Austin, TX)
- …functional groups + Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development projects budget process ... quality **_Communications_** + Accurate and timely reporting status regulatory projects; escalate unresolved issues to appropriate executive leadership + Steward… more
- Abbott (Alameda, CA)
- …Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical investigations, ICH guidelines. . Experience ... with outside regulatory agencies and trade associations, develop innovative regulatory compliance strategy, and provide executive management with … more
- Penn Medicine (Philadelphia, PA)
- …reporting and monitoring of all aspects pertaining to pharmacy payer audits and regulatory compliance . + The Ambulatory Regulatory Technician is responsible ... pharmacy locations insurance audit requests, as well as proactive audits and regulatory compliance . The Ambulatory Regulatory Technician services more… more