- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …this role, a typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC /CP regulatory issues and develop appropriate strategies to mitigate… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical ... Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …assigned and perform the duties outlined below. This role includes mentoring Regulatory Affairs staff, supporting project teams and development partners, and ... a typical day might include the following:** + Lead CMC /CP product development activities from a regulatory ...market applications, and post market requirements with input from senior management. + Represent CMC /CP RA at… more
- Merck (Rahway, NJ)
- **Job Description** **Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director/ Senior ... but are not limited to: + Serve as a Regulatory CMC Project Lead and provide ...Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the ... years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry experience… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director, Regulatory Affairs - Clinical (Neuroderm), may be ... plans to facilitate timely drug development and registration. The Senior Director, Regulatory Affairs -...support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... global projects. + Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- Deloitte (New York, NY)
- …relevant consulting experience. + 4+ years of Life Sciences industry experience in the regulatory affairs function to include: + Regulatory operating model ... a digitally enabled, equitable future of health As a Senior Manager in our AI & Data team are... digital transformations / innovations + Submissions management, labeling, CMC change control and/or LCM processes + Veeva RIM… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …independently, as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC /Formulations, Biostatistics, Legal, ... strategy, working closely with other functional areas such as commercial, regulatory , pharmacovigilance, CMC , early clinical, and pre-clinical development in… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is ... responsible for the management of global regulatory leads with product and disease state expertise for specific therapeutic area(s). Provides oversight for the… more
- Bristol Myers Squibb (Summit, NJ)
- …Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs , and other Cell Therapy Development ... QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions. + Supports the overall product quality… more