- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the ... INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC ...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Principal Scientist Regulatory Affairs - OncologyAt our company, we aspire to be the premier research-intensive biopharmaceutical ... applications.Communicating with Agencies and attending Agency meetings as needed to assist the global regulatory lead.Participating as an active member on the … more
- Organon & Co. (Jersey City, NJ)
- …+ Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification?of? ... **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing… 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
- Organon & Co. (Jersey City, NJ)
- …development programs with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, Manufacturing ... and Controls ( CMC ), medical affairs and business development. Non-Clinical Safety Assessment Representative is...books, or other regulatory communications for regional regulatory submissions or renewals for global products… 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)
- **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
- Organon & Co. (Jersey City, NJ)
- … product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating ... for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Primary responsibilities include, but… 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
- Sanofi Group (Morristown, NJ)
- …you'll drive breakthroughs that could turn the impossible into possible for millions. Our Global Regulatory Team is involved in developing regulatory product ... of drug products. As a key member of the Global Regulatory Team (GRT), and strategic partner...industry experience, including at least 3 years of relevant Regulatory Affairs experience or Advanced degree (PharmD,… more
- Sanofi Group (Morristown, NJ)
- …with all key stakeholder in GPT and Global Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the ... R&D components of the brand optimization strategy in close collaboration with Market Access, Global Commercial and Medical Affairs , as Active member of GPT. +… more
- Merck (Rahway, NJ)
- **Job Description** Associate Principal Scientist Regulatory Affairs - Oncology At our company, we aspire to be the premier research-intensive biopharmaceutical ... and attending Agency meetings as needed to assist the global regulatory lead. + Participating as an...colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC , and other functional areas. +… 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
- 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
- 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 Mitsubishi Tanabe Pharma Group,… 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
