- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer ... Position Summary:We are seeking a detail-oriented and tech-savvy student to join our Global Regulatory Affairs Labeling Operations team as an intern.The … more
- Parexel (Trenton, NJ)
- …Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and ... Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role,...role, you will be responsible for developing and executing global regulatory strategies for our clients' marketed… more
- Terumo Medical Corporation (Somerset, NJ)
- …stakeholders, to include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs , Quality Systems, Marketing, Sales as well as external ... documents and scientific presentations in cooperation with the Clinical, Medical, & Regulatory Affairs Teams, Key Opinion Leaders and physician investigators. +… more
- Nestle (Bridgewater, NJ)
- …and nutrition for patients and consumers. **Position Summary:** Reporting to the Head of Global Regulatory Affairs Pharma, the Regulatory Affairs ... Labeling Lead will be responsible for managing regulatory strategy and material approvals within their areas of...alignment with the overall company strategy. In collaboration with Global Regulatory Affairs leads and… more
- J&J Family of Companies (Raritan, NJ)
- …(GRLs) and other functional area partners (clinical, safety, market access, commercial, medical affairs ) to ensure the global labeling strategy aligns with ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...primary labeling . + Represent global labeling in Global Regulatory teams… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling , medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Sumitomo Pharma (Trenton, NJ)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international...to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an… more
- Kelly Services (Bridgewater, NJ)
- ** Global Labeling Lead Specialist** Kelly(R) Science & Clinical is seeking a Global Labeling Lead for our client based in Bridgewater, NJ. If you're ... Tampa, FL or St Louis, MO** **Compensation: $45-47.50 hr** **Remote option possible** The Global Labeling Lead is responsible for leading labeling artwork… more
- Parexel (Trenton, NJ)
- …Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and ... Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role,...role, you will be responsible for developing and executing global regulatory strategies for our clients' marketed… more
- Bausch + Lomb (Trenton, NJ)
- …+ Drive regulatory strategies for clinical, non-clinical, CMC and labeling development plans, ensuring alignment with global requirements. + Provide ... eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and...of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work… more
- Sumitomo Pharma (Trenton, NJ)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... primarily function as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Sumitomo Pharma (Trenton, NJ)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Bausch + Lomb (Trenton, NJ)
- …with ongoing regulatory training related to products. + Works closely with the Regulatory Affairs labeling group in order to assess and determine the ... labeling changes on product promotion. + Communicate with regulatory authorities on the companies behalf. + Actively leads...preferred or equivalent + Minimum of 6 years in Regulatory Affairs or relevant experience in a… more
- J&J Family of Companies (Titusville, NJ)
- …profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Regulations, Process Improvements, Product Packaging Design, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Standard… more
- Colgate-Palmolive (Piscataway, NJ)
- …US and Canadian markets. This position is primarily responsible for reviewing and approving labeling materials for Regulatory , as well as other regulatory ... support for both existing and new product development activities, focusing primarily on labeling reviews. + Provide regulatory guidance to Marketing regarding … more
- Bristol Myers Squibb (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director, Global Regulatory Strategy, Neuroscience** **Position Summary:** The ... selected candidate will have leadership responsibility for global regulatory strategy within a development team...PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry.… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Global Program Leads within the ICV Global Program Leadership ... late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision… more
- J&J Family of Companies (Raritan, NJ)
- …R&D and GCSO functions, including the Clinical Development Team (CDT), Commercial, Medical Affairs , and Global Market Access CoE to ensure optimal launch ... New Jersey, United States of America **Job Description:** **Director, Global Compound Market Access Leader, Neuroscience (2 positions)** **About Neuroscience**… more
- Ascendis Pharma (Princeton, NJ)
- …promotional assets for assigned product(s), and collaborate with Commercial, Legal, and Regulatory for development and review of Labeling , advertising, and ... Regulatory , Clinical Development, Clinical Operations, Compliance, Pharmacovigilance, Biometrics, Global Communications, and other functional group contributors to support… more
- J&J Family of Companies (Titusville, NJ)
- …via matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality ... clinical study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are… more
