- GRAIL (Albany, NY)
- …position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual ... 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings. + Serve as a key member of the Regulatory… more
- Ankura (Lexington, NY)
- …relating to compliance with the federal False Claims Act; Anti-Kickback Statute; Food Drug and Cosmetic Act; Department of Justice and Health and Human Services ... association guidance; and international compliance standards governing pharmaceutical and medical device operations. You will be joining a team of industry experts… more
- Guidehouse (New York, NY)
- …particularly for specialty medications (eg, high cost, biologics, CAR-T, REMs, drug - device combinations), Organizational design and change management, and ... design, implementation, and monitoring services to pharmaceutical, biotechnology, and medical device , companies. We support our clients across the lifecycle of a… more
- Regeneron Pharmaceuticals (Troy, NY)
- …the development and execution of global regulatory strategies for the assigned drug / device portfolio. This role involves overseeing regulatory affairs staff, ... combination products, and/or small molecule drugs. + Previous experience with device regulatory requirements and development processes for combination products is an… more
- Mastercard (New York, NY)
- …and governments realize their greatest potential._ **Title and Summary** Director , Digital Authentication Product Management Overview: The Digital Payments team ... is looking for a Digital Authentication Director to lead the commercialization of Passkey authentication in US and Canada. This individual will be the subject matter… more
- Sumitomo Pharma (Albany, NY)
- …with multiple therapeutic modalities (eg API, solid dosage, biologics, gene therapies, drug / device combination products) is required. Must be familiar with EMA ... dynamic, highly motivated, and experienced individual for the position of ** Director , Commercial Manufacturing Validation** . This role functions within SMPA's… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …(eg, PhRMA, EFPIA, JPMA, etc.). + Demonstrate solid working knowledge of the drug , biologic, and device development process, laws, regulations, and guidelines ... The Associate Director of Regulatory Intelligence leads the collection and...business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death &… more
- Akwesasne Mohawk Casino Resort (Hogansburg, NY)
- Job Title: Communications Administrator Department: Information Technology Reports To: Director of IT FLSA Status: Exempt Closing Date: Open Until Filled SUMMARY: ... processes purchase requests, and oversees the execution of the company's mobile device policy, ensuring compliance and efficient management of corporate and personal… more
- ThermoFisher Scientific (Grand Island, NY)
- …a leading provider of global CRO solutions. We provide comprehensive drug development, laboratory and lifecycle services to customers across pharmaceutical, ... biotechnology, medical device , academic and government entities. By harnessing innovative technology...a **Digital Product Portfolio Head** (known internally as Sr Director , Digital Product) to own the strategy, prioritization, and… more
- Southern Glazer's Wine and Spirits (Syosset, NY)
- …of our Top Shelf Benefits, including comprehensive medical and prescription drug coverage, dental and vision plans, tax-saving Flexible Spending Accounts, disability ... and gross profit targets as set by the Sales Director . + Communicate local program spending effectiveness to maximize...a computer (eg, keyboard, mouse, and monitor) or mobile device + Physical demands with activity or condition may… more