- United Therapeutics (Albany, NY)
- … affairs or a related area of study or 7+ years of biologic or pharma regulatory experience with a PhD in life sciences, quality, regulatory affairs or ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...a regulatory strategist who will advise on regulatory pathways, managing documentation and timelines, and supporting the… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. + ... Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with advancements in… more
- Mount Sinai Health System (New York, NY)
- …use of research tools. 8. Ensures compliance with safety and regulatory requirements. **_Requirements:_** PhD **Qualifications** . **Responsibilities** . **About ... Us** **Strength through Unity and Inclusion** The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. + ... Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory , Process Development, Analytical Development, and CDMO technical teams. + Stay current with… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The role leads a group within Regeneron's Regulatory Affairs organization that provides guidance to Research, Regeneron Genetics Center, Regeneron Cellular Medicine, ... the Oncology and Hematology Clinical Development Units on regulatory strategies for the development of Oncology & Malignant...be for you if ** + Terminal degree (MD, PhD ,, PharmD, etc.) in a scientific discipline related to… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced ... (BLAs) and Marketing Authorization Applications (MAAs). They will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying… more
- New York State Civil Service (New York, NY)
- NY HELP No Agency Financial Services, Department of Title Assistant Chief Regulatory Unit (Director Financial Services Programs 2, SG-33) Occupational Category Other ... is seeking candidates for the position of Assistant Chief Regulatory Unit in the Health Bureau. Duties include, but...to, the following:* Oversees the activities of the three Regulatory Compliance Units and works with the Assistant Chief… more
- Wolters Kluwer (New York, NY)
- …to help save lives, improve how we do business, and build better judicial and regulatory systems. We help them get it right. This role is part of the Advanced ... we support, VitalLaw, is trusted by customers to help legal professionals achieve regulatory compliance and better understand complex legal issues in key areas like… more
- Sumitomo Pharma (Albany, NY)
- …Team. + Collaborate with the process and analytical development, quality, and regulatory functions to establish a robust, compliant clinical supply chain to support ... company objectives. + Champion regulatory and technical documents for regulatory submissions...domestically and international if/when needed. **Education and Experience** + PhD or MS Chemistry, Biology, or related field is… more
- New York State Civil Service (New York, NY)
- …responding to outbreaks, and maintaining alignment with institutional and regulatory health standards.* Emergency Response: Address urgent and after-hours medical ... development and optimization, interpret clinical and experimental data, and promote regulatory compliance.* Regulatory Compliance: Ensure that all research… more