- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... 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)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Merck & Co. (Rahway, NJ)
- …part of our company's Social Business Innovation (SBI) department within Corporate Affairs . The ESG team works cross-functionally with senior leaders and partners in ... sustainable and healthy future for people and communities everywhere.The role of Associate Director, ESG Strategic Reporting is a unique opportunity to join our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… 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 ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical ... Affairs ' externally sponsored clinical research (ESR) initiatives, ensuring strict...as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance: Understand study conduct from supply… 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 ... under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and by tracking and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary: The Associate Director, Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director, Regional Marketing Conventions & Field Programs is responsible for managing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... Global Safety Lead(s), Global Safety Lead(s) and Global Safety Scientist(s)/ Associate within Safety Surveillance. Essential Functions Innovation and change… more
- Haleon (Warren, NJ)
- …projects. **What will your individual contribution at Haleon be?** The expectation for the Regulatory Affairs Associate role will be as follows: + Work ... goal. Right now, we're looking for Co-Ops student in Regulatory Affairs to join us to do...extremely useful for Haleon. This role will provide the Associate with the opportunity to learn about FDA submission… more
- Adecco US, Inc. (Clark, NJ)
- Adecco is currently assisting a local client in their search to fill a ** Regulatory Affairs Office Associate III** job opportunity located in **Clark, NJ ... + Knowledge of MS Office Suite Apply Today to be considered for this ** Regulatory Affairs Office Associate III** job and any other positions with Adecco.… more
- Adecco US, Inc. (Clark, NJ)
- Adecco is currently assisting a local client in their search to fill a ** Regulatory Affairs Office Associate ** job opportunity located in **Clark, NJ 07066 ... skills + Attention to details Apply Today to be considered for this ** Regulatory Affairs Office Associate ** job and any other positions with Adecco. **Pay… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate 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… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... and promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. + Detail-oriented with… 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 ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- Bristol Myers Squibb (Madison, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …assigned and perform the duties outlined below. This role includes mentoring Regulatory Affairs staff, supporting project teams and development partners, and ... will be responsible for leading the development and execution of global regulatory strategies for biologic products and combination products for the product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... 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
