- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing … more
- Parexel (Trenton, NJ)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings… more
- Taiho Oncology (Princeton, NJ)
- …and enhance your skills. Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned ... an agreed upon plan. Performance Objectives: + Independently develops global regulatory CMC Strategies and...be required to perform other duties, as assigned. Job Details Job Family R&D Job Function Regulatory Affairs… more
- Parexel (Trenton, NJ)
- …and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan ... CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as..., Project Management). + 3+ years proven experience in regulatory affairs , particularly in CMC … more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Sumitomo Pharma (Trenton, NJ)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... of the product + Supports the global regulatory lead (GRL) and the CMC ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… 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...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Parexel (Trenton, NJ)
- …EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering ... country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life… more
- Organon & Co. (Jersey City, NJ)
- … product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more
- Sanofi Group (Morristown, NJ)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global ), in early ... teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner...and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Global Program Leads within the ICV Global Program Leadership ... late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision… more
- Adecco US, Inc. (Morristown, NJ)
- …organizational templates. + Collaborate with cross-functional teams including Quality, Manufacturing, Global Regulatory Affairs , and Contract Manufacturing ... Adecco Healthcare & Life Sciences is seeking a skilled ** CMC Regulatory Technical Writer II** to support a global pharmaceutical client in lifecycle… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Manufacturing and Controls ( CMC ), medical affairs and business development are critical to the success...to inform mitigation strategies in accordance with regional and/or global regulatory requirements. + Actively participate in… more
- Sanofi Group (Morristown, NJ)
- …their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse ... of products. The team is part of the GRA CMC & GRA Device Department within Global ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Tanabe Pharma Group, including… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and Teva Standard Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs , CMC , Biostatistics, GCO, in the execution ... will be a key contributor to INDs, NDAs, BLAs, and other global regulatory filings and publications. The Director will foster relationships with opinion leaders… more
- Organon & Co. (Jersey City, NJ)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans....live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- Sanofi Group (Morristown, NJ)
- …work with medical leads, data managers, statisticians, clinical supplies managers and regulatory affairs specialists, etc.. + ensure compliance with relevant ... + May be a core team member of the Global Project Team (GPT), representing and accountable for CSO...Collaborates upfront with CSCO, Demand and Supply Leader and CMC Leader in order to secure all aspects linked… more