- Bayer (Whippany, NJ)
- …clinicians, clinical operations, bioanalysis, biomarker specialists, pharmacometrics, pharmacovigilance, regulatory affairs, statistics, and PS ( CMC ) groups. ... clinical operations, data management, pharmacometrics, medical writing statistics), pharmacovigilance, PS ( CMC ), regulatory affairs to best use CP concepts… more
- Merck (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... Pharmaceutical Development, Pharmaceutical Microbiology, Pharmaceutical Sciences, Pharmacokinetics, Product Development, Regulatory CMC , Software Development {+ 3 more}… more
- Merck (Rahway, NJ)
- …(DCT) leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen… more
- Merck (Rahway, NJ)
- …scale-up and validation support, preparation of Chemistry, Manufacturing, and Controls ( CMC ) documents for global regulatory submissions, and responses to ... Experience with method development and validation + Familiarity with authoring relevant CMC sections of regulatory submissions Current Employees apply HERE… more
- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than...Lead for Specialty Care Combination Products will oversee key regulatory activities and report to the GRA Device Team… more
- Merck (Rahway, NJ)
- …control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + ** CMC RA** : Experience supporting/writing ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… 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
- System One (Park Ridge, NJ)
- …and Sterilization understanding + Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC + Strong knowledge of QbD principles and ... technical direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through commercialization.… more
- System One (Florham Park, NJ)
- Job Title: Regulatory Operations Senior Publisher - Contractor Location: Florham Park, New Jersey Type: 12-month contract (renewable) Compensation: $40 - $57 hourly ... This role will support in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission Gateways (ESG),… more
- Deloitte (Morristown, NJ)
- …experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and ... automation for pharmaceutical regulatory content or regulatory intelligence; Veeva RIM...generating submissions packages + Experience with submissions management, labeling, CMC change control and/or LCM processes + Understanding of… more