- Astellas Pharma (Northbrook, IL)
- …data review, quality and conduct at external bioanalytical vendors and ensuring regulatory compliance . + Provide technical expertise and guidance over the ... you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries...assay life cycle. + Contribute to regulatory submission documentation ie, INDs, IBs, NDAs/BLAs + Ability… more
- AbbVie (North Chicago, IL)
- …clinical programs are innovative and aligned with regional demands. + Ensure compliance with regulatory requirements and global standards in clinical ... at driving regional development efforts, while leveraging expertise in the unique regulatory and operational environments of Japan and China to foster innovation and… more
- Amgen (Cambridge, MA)
- …The successful candidate will lead collaborations with cross-functional teams to ensure compliance with regulatory standards and industry best practices. This ... extensively with internal and external stakeholders ie manufacturing, suppliers, quality, regulatory , senior management, etc. + Drive and influence key opinion… more
- Lilly (Indianapolis, IN)
- …reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at ... of the medical team _(and direct reports, if applicable)_ are in compliance with current local and international regulations, laws, guidance (for example, FDA,… more
- BeOne Medicines (Emeryville, CA)
- …executes Crisis Management response plan, reviews ongoing issue and plan + Reviews regulatory inquiry to lead strategizing the nature of response, best course of ... response + Leads responses and contributes to formal response provided to regulatory agencies, reviews draft response, and manages approval of response + Actively… more
- Boehringer Ingelheim (Fulton, MO)
- …in the execution of a global development strategy for new pharmaceutical products (early research through regulatory submission). Independently operates, ... supervision; + Develop, validate, troubleshoots, modify and utilize methods in compliance with global regulatory requirements. + Independently operates,… more
- Bristol Myers Squibb (Devens, MA)
- …submissions in accordance with regional and national regulations. Deliver overall chemical compliance company wide. + Conduct regulatory monitoring and impact ... diverse multi-functional teams to deliver global chemical registrations, achieve chemical compliance and implement action plans for chemicals of concern. In addition… more
- PCI Pharma Services (Rockford, IL)
- …to ensure compliance with FDA, ISO 13485, and other applicable regulatory standards. This role is critical in supporting new product introductions, technology ... + Develop and execute validation master plans, protocols, and reports in compliance with internal procedures and regulatory expectations. + Provide validation… more
- Merck (Lower Gwynedd, PA)
- …Management System (LIMS), Management Process, Neutralization Assays, Node.js, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Phytochemistry, Process ... pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los… more
- Amgen (Thousand Oaks, CA)
- …commercial value and access organization on a wide variety of legal and regulatory issues concerning complex contracting and pricing strategies, as well as sales and ... to Amgen products to patients. + Advising key stakeholders on legal, regulatory and policy developments, as well as industry related government enforcement actions… more