- Sumitomo Pharma (Frankfort, KY)
- …of adverse event (AE) management and reporting processes, ensuring compliance with global regulatory requirements. + Conduct routine AE case quality checks, ... partners. Support Alliance Management to ensure PVAs are compliant with global regulatory requirements and support the implementation and oversight of PVA… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. + Advanced knowledge of regulatory ... interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be...Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary… more
- Medtronic (Los Angeles, CA)
- …related to Medtronic Diabetes products. This role ensures compliance with global regulatory requirements, drives cross-functional collaboration, and oversees the ... Experience leading Field Corrective Actions / Recalls + Expert knowledge of global regulatory requirements (eg, FDA 21 CFR 806, EU MDR) for field actions/recalls… more
- BeOne Medicines (Emeryville, CA)
- …+ Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance. **Education Required:** + PharmD,… more
- Astellas Pharma (Northbrook, IL)
- …Regulatory and HTA Engagement + Represent Astellas on all statistical matters in global regulatory interactions (eg, FDA, EMA, PMDA). + Guide preparation of ... work are encouraged to apply. **Purpose and Scope:** The Global Statistical Lead (GSTATL) for Solid Tumor Oncology is...external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance… more
- AbbVie (Irvine, CA)
- …May coordinate and develop information for reports submitted to the FDA and Global Regulatory Authorities. + May initiate research projects compatible with ... regulatory submission is expected. + Direct experience with regulatory bodies (US and Global ) is highly...Direct experience with regulatory bodies (US and Global ) is highly advantageous. + Proven ability to collaborate… more
- Microsoft Corporation (Redmond, WA)
- …performance of a critical outsourced managed service (3rd-party vendor) operating our global regulatory compliance and payments activities. This role is ideal ... decision-making. Regulatory Compliance Governance . Support the execution of global regulatory and payment compliance processes. . Maintain audit-ready… more
- Dell Technologies (Franklin, MA)
- …operating in a complex global environment. We ensure product compliance to global regulatory , market and customer requirements in all our target regions. We ... **Energy Compliance Test Engineer** Our Regulatory Engineering team thrives on the challenge of...impact as an **Energy Compliance Test Engineer** at our ** Global Product Compliance Engineering Lab** in **Franklin, Massachusetts.** **What… more
- Amgen (Thousand Oaks, CA)
- …improvements, and support method and validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections and RTQs ... management activities. The role will involve close partnership with local and global Quality and will also involve representation of Attribute Sciences on … more
- Pfizer (New York, NY)
- …working collaboratively with Oncology Early-and-Late Clinical Development, CMO, Safety, Oncology Regulatory Strategy, Global Value and Access and other functions ... the Program Strategy Management Group Lead. + The Program Lead will support Global and/or US Medical Franchises, l by providing strategic partnership and operational… more
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