- Sanofi Group (Morristown, NJ)
- …with the M&S Hubs supporting the technical writing function. + Collaborate closely with Global Regulatory Affairs (GRA) CMC to align on dossier strategies. ... **Job Title:** Manager , CMC Development and Dossiers **Location**...content generation for reports leading to the authoring of CMC dossier content for regulatory submissions and… more
- Deloitte (Morristown, NJ)
- …(ie: Veeva Vault RIM, Lorenz docuBridge, MasterControl, or similar); and + Involvement with CMC modules (Module 3 of CTD/eCTD) for global submissions, as well as ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed… more
- Bausch Health (Bridgewater, NJ)
- …+ Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory contact with Regulatory ... Join our global diversified pharmaceutical company enriching lives through our...drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/… more
- Merck (Rahway, NJ)
- **Job Description** The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of… more
- Merck (Rahway, NJ)
- **Job Description** The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …the resolution of CAPAs . Partner with Regulatory to ensure labels meet global regulatory requirements and filings accurately reflect the global supply ... the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines ... real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the supply chain activities… more
- Bristol Myers Squibb (Summit, NJ)
- …re-engaging the body's immune system to treat cancer. We are looking for a Manager / Senior Engineer to join the Breyanzi Product Stewardship Cell Therapy Technical ... for process changes, coordinating technical alignment, and lead implementation at a global level. This highly cross-functional role collaborates across all CMC … more
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