- Sanofi Group (Morristown, NJ)
- **Job Title:** Manager , CMC Development and Dossiers **Location** : Morristown, NJ **About the Job** The Manager , CMC Development and Dossiers is ... content generation for reports leading to the authoring of CMC dossier content for regulatory submissions and...the authoring of CMC dossier content for regulatory submissions and quality documentation. This is conducted ensuring… more
- Deloitte (Morristown, NJ)
- …(ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...+ 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Deloitte (Morristown, NJ)
- …health Recruiting for this role ends on 8/31/2025 Work You'll Do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and… 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 ... and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …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 ... Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to develop… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the supply chain activities ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
- BeOne Medicines (Pennington, NJ)
- Reporting to the Vice President, General Manager of US Manufacturing, Hopewell, NJ., this position plays a leading role in driving process robustness, technology ... and process troubleshooting. This position involves close collaboration with the CMC , Process Development, Manufacturing, Quality Control, Quality Assurance and … more
- RWJBarnabas Health (Toms River, NJ)
- …Location: 99 Highway 37 West, Toms River, NJ 08755 Job Title: RN Location: CMC Nursing Department Name: Nursing Float Pool Req #: 0000203902 Status: Hourly Shift: ... with the comforts of hometown care. Opened in 1961, CMC has evolved into the state's newest teaching hospital...of practice defined by the Nurse Practice Act and regulatory standards and assures awareness of ethical standards of… 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 ... at a global level. This highly cross-functional role collaborates across all CMC functional areas and drug product manufacturing sites to ensure project advancement,… more