- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC...and escalate potential regulatory issues to Organon Regulatory CMC management, as needed **Required Education,… more
- Sanofi Group (Morristown, NJ)
- …strategy; in collaboration with R&D functions, Industrial Affairs , Global Regulatory Affairs . + Coordinate the submission of CMC regulatory files and ... thought was possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects… more
- J&J Family of Companies (Raritan, NJ)
- …in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs , CMC Regulatory Affairs , Product Artwork, and ... profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory … more
- Sanofi Group (Morristown, NJ)
- …products 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 1800 people. The GRA Device Lead for Specialty Care… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more
- System One (Florham Park, NJ)
- …documents for electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs , Clinical Development, and Quality Assurance, to ... are met. + Ability to work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance in a… 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 and ... late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation of… more
- Cardinal Health (Trenton, NJ)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... submissions within the discipline of chemistry, manufacturing, and controls ( CMC ). The _Sr. Coordinator, Regulatory Submissions Operations_ will use… more
- Sanofi Group (Morristown, NJ)
- …toward all GPT members, including eg project management, clinical operations, regulatory , safety, translational medicine, statistics, CMC , IA **Basic ... The GPH will be delegated such responsibilities as interaction with regulatory /health authorities (HA), approval of documents and product label, as appropriate.… more