- Bausch + Lomb (Albany, NY)
- …operational excellence, compliance , and timely execution of deliverables. + Drive regulatory strategies for clinical , non- clinical , CMC and labeling ... adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance , influencing key stakeholders, and optimizing business outcomes.… more
- Merck (Albany, NY)
- … Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical ... content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory ...Regulatory Affairs, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance , … more
- Mohawk Valley Health System (Utica, NY)
- …initiatives and support of patient advocate processes. + Oversee enterprise-wide compliance with ongoing regulatory and accreditation readiness sustaining ... of the response needed. + Collaborates with many other departments to ensure compliance with regulatory information. + Ongoing relationships with DOH, DNV,… more
- Bausch + Lomb (Albany, NY)
- …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
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and ... a Manager, of Advertising and Promotion to join our Regulatory Affairs team!! **In this role, a typical day...commercial team's objectives, while maintaining the necessary state of compliance and corporate integrity. **This role might be for… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and ... (BLAs) and Marketing Authorization Applications (MAAs). They will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying… more
- Sumitomo Pharma (Albany, NY)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Pfizer (Pearl River, NY)
- …(Minimum Requirements)** + BS is required. MS, PharmD, or PhD preferred + Prior clinical regulatory affairs experience in vaccines is required, at least 8 years. ... responsible for developing and executing global (Influenza/COVID-19) and US (COVID-19) regulatory strategies and ensuring compliance with applicable regulations.… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Regeneron Genetics Center, Regeneron Cellular Medicine, the Oncology and Hematology Clinical Development Units on regulatory strategies for the development ... The role leads a group within Regeneron's Regulatory Affairs organization that provides guidance to Research,...are met within specified timelines and vital state of compliance is maintained. In addition, the position acts as… more
- Mount Sinai Health System (New York, NY)
- …2 years managing investigator-initiated trials preferred. + Proven track record in regulatory compliance , project management, and team leadership. + Progressive ... Prioritize resources and allocate tasks to ensure timelines and objectives are met. ** Regulatory Compliance and Quality Assurance:** + Ensure all trials adhere… more