- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director, Regulatory Affairs - Regulatory Project Management (RPM) provides ... Associate Director RPM is responsible for supporting the global regulatory lead (GRL), US regulatory ...provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT)...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Genmab (Plainsboro, NJ)
- …information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy ... and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading… more
- Genmab (Plainsboro, NJ)
- … Affairs Solid Tumors Strategy will report to the Senior Director, US Medical Affairs Solid Tumors Strategy Lead . S/he will provide medical affairs ... US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross functional… more
- Novo Nordisk Inc. (WA)
- …or advanced degree required 8+ years of policy development, advocacy, legal, government affairs or other relevant experience required Expert knowledge of issues ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access and Public Affairs (MAPA), Portfolio Strategy, Commercial Excellence, Regulatory Affairs , and other relevant NNI departments to ensure alignment ... embark on shaping our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic direction and initiatives… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal...life cycle activities Health Systems strategy: Collaborates with medical affairs and market access teams to inform a health… 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 ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other...disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product ... Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborations within and across line functions, eg Clinical Development, Medical Affairs , Regulatory Affairs , Clinical Operations. Formulates strategic ... with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge.This position independently… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. - Specifically, The Executive Clinical Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … understanding of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well as the healthcare ... and new product commercialization assets (3 years prior to launch). They will lead the development and implementation of brand plans, development of capabilities to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings with CROs, License ... Responsible for development and maintenance of a PVA repository Lead development of contract templates in cooperation with Legal...and international PV regulations. Act as a subject matter expert in regulatory intel for PV and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... a consistent brand/therapy area vision and message. Relationships Reports to Brand Lead or Consumer Strategy Lead . Collaborates with cross-functional teams,… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report and continued process verification ... to close nonconformance records and identify necessary corrections.Key Responsibilities Lead cross functional investigations independently from end to end. Ensure… more
- dsm-firmenich (Princeton, NJ)
- ** Lead Expert Regulatory Affairs Pet Food** **Location: Plainsboro, NJ** **Hybrid** Are you a junior Regulatory Affairs professional ready to ... in this niche space where you can learn and grow. We are hiring a Lead Expert Regulatory Affairs Pet Food to support our Taste Texture and Health (TTH)… more
- J&J Family of Companies (Cincinnati, OH)
- …Solutions, part of the Johnson & Johnson Medtech Surgery, is recruiting for a Senior Regulatory Affairs Program Lead . The preferred location for this role is ... joining our growing regulatory team, the Sr. Regulatory Affairs Program Lead will...health authorities' submissions technical documents. + Serves as a Regulatory Affairs subject matter expert … more
- Amazon (Arlington, VA)
- …communication system and make a difference in bridging the digital divide. The Senior lead , Licensing and Regulatory Affairs works to align the licensing ... with national, regional and international telecommunications organizations. The Senior Lead , Licensing and Regulatory Affairs ...* Demonstrated ability to be both a substantive issue expert and a manager of complex regulatory … more
