- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA Travel Ability to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan ... 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)
- …a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. Gain endorsement ... the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project... risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... transparent ways of working across the Alliance within US regulatory affairs and will work closely with...alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and… more
- Merck & Co. (Rahway, NJ)
- …updated on emerging regulations and industry trends affecting device quality and regulatory affairs .Strategic ContributionsServe as a key member of the device ... to the strategic direction of the company's product pipeline and regulatory strategy .Drive operational excellence initiatives that improve quality, compliance,… more
- Merck & Co. (Rahway, NJ)
- …Work effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, Business Development ... strategy , target product profile development, health authority interactions, global regulatory filing strategy , launch readiness reviews, organized customer… 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 sub ... including working with contract manufacturing organizations CMO. This position develops strategy , prepares content templates and leads technical teams in preparation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings with CROs, License ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for ... more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible for managing the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,)...colleagues in order to establish a globally aligned GCLP/GLP strategy across DS teams. Establishes and / or develops… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents ... primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics...of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and… more
- 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)
- …+ Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. Gain endorsement from ... the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project... risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- AbbVie (Florham Park, NJ)
- …YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for setting strategy and leading ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
