- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all ... or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... minutes. This position develops awareness of global requirements through support of global submissions and this position serves as the RA CMC representative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and Promotion ( RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... biologic products. + Significant experience leading development and execution of regulatory submissions of promotional materials for marketed prescription drug… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all ... global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions ,...pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content ... compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding:...post-approval submissions . In this role, the GRS-CMC Associate Director , Biologics will serve as the… 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 CMC ... develops awareness of global requirements through support of global submissions and this position serves as the RA...** Regulatory Knowledge:** Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative… more
- System One (Florham Park, NJ)
- …regions, and provide insights to the Senior Director and Associate Director . + Contribute to managing regulatory risks and opportunities related to QOL ... Senior Manager, Regulatory Affairs Strategy - Contractor Must...involves actively contributing to the development and execution of regulatory strategies, regulatory submissions , and… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …of bipolar depression in adults as monotherapy and as adjunctive therapy. The Associate Director / Director of Medical Writing provides support for the ... Regulatory documents, and responses to health authority information requests. The Associate Director / Director of Medical Writing must have experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations,… more
- Bristol Myers Squibb (Madison, NJ)
- …MS or commensurate experience preferred **Experience Requirements** Significant experience in regulatory affairs (eg 3-5 years) **Key Competency Requirements** ... all regulatory interactions with FDA/global regulatory authorities + Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and… more
