- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan ... in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred **Travel** Ability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… more
- Merck (Rahway, NJ)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... **Job Description** Our Regulatory Affairs team bring new medical...regulatory strategy for their assigned products, in order to optimize… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Development, may be called upon to ... practical, workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … agencies. You will lead and oversee the Global Regulatory Affairs (GRA) Labeling organization, inclusive of labeling strategy and labeling operations ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global… more
- Merck (Rahway, NJ)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... Lead, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs , Precision Medicine you will ... regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional...need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and… more
- Bausch Health (Bridgewater, NJ)
- …**KEY ACTIVITIES/** **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead and grow individuals on the Regulatory ... standards and other best practices guidelines + Identify opportunities to streamline Regulatory Affairs processes to promote operational excellence + Provide… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... regulatory agencies. You will manage the commercial regulatory strategy and execution of such for...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... strategy . + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **i-hybriPosition Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy . + Knowledge of CMC regulatory ... database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content development,… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the clinical ... Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy /Portfolio Management, Global Device… more
- Merck (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... performance against metric targets. + Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own. + Lead… more
- AbbVie (Florham Park, NJ)
- …scientific and medical expertise to cross-functional teams, including research and development, regulatory affairs , market access, and commercial teams. + Ensure ... be determined by the qualifications listed below. The Medical/Scientific Director , Medical Affairs - Psychiatry Pipeline is...compliance with regulatory and ethical standards in all medical … more
- Merck (Rahway, NJ)
- …for the Global Process Lead Network, as well as defining the strategy and approach to optimize end-to-end processes and ensure consistency and standardization ... Business Process Management capabilities, including developing and executing an integrated strategy for the continued evolution and effective management of the GRACS… more
- Hackensack Meridian Health (Edison, NJ)
- …mission to transform healthcare and serve as a leader of positive change. The ** Director , External Affairs ** for HMH is responsible for assisting the SVP, Chief ... an FQHC strategy . **Responsibilities** A day in the life of a ** Director , External Affairs ** at **Hackensack Meridian** **_Health_** includes: + Reports to… more
- AbbVie (Florham Park, NJ)
- …and Pipeline Commercial cross-functional teams and drives the development of medical affairs objectives aligned with strategy . + Provides scientific and ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Medical Director , US Medical, Multiple Myeloma will report to the Senior Director ... the US Commercialization organization, WW Medical, Clinical Research and Development, Regulatory , Translational Development, and Market Access, and will lead the US… more