- 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
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and… more
- Parexel (Trenton, NJ)
- …of the pharmaceutical industry drug development process and willingness to learn global labeling regulatory requirements and industry practice + ... you'll be the go-to expert for global labeling , working side-by-side with client teams across Regulatory... labeling , working side-by-side with client teams across Regulatory Affairs , Technical Operations, Safety, and Commercial.… more
- J&J Family of Companies (Raritan, NJ)
- …a single submission. **Director, Labeling Science and Technology Leader - Cross-Regional Regulatory Affairs ** Are you ready to shape the future of ... a dynamic and visionary leader to join our Cross-Regional Regulatory Affairs team as **Director, Labeling...of the global pharmaceutical landscape, including R&D, regulatory affairs , and commercial strategy. + Minimum… 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)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Innovative Medicine R&D is recruiting for a Senior Manager, Global Labeling Product Leader. This position is...develop methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and… 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)
- ** Regulatory Affairs Specialist Labeling ** Kelly(R) Science & Clinical is seeking a Regulatory Affairs Specialist - Labeling for our client based ... approvals + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product lifecycle including… more
- Bristol Myers Squibb (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs ** **Description** : The role of Associate ... Director of US Commercial Regulatory Affairs requires the ability to apply...and subpart E and H submissions + Ensure full regulatory compliance of all promotions with approved labeling… 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)
- …Associate Director Regulatory Affairs . The Associate 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 ...Ideally with a minimum of 4 years focused in regulatory affairs The base salary range for… 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
- 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
- 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
- Actalent (Branchburg, NJ)
- …& Product Labeling Specialist is responsible for ensuring compliance with global regulatory requirements related to chemical safety documentation and product ... databases. + Create and update product labels to meet global regulatory requirements, including GHS pictograms, hazard...requirements to internal stakeholders. Essential Skills + Expertise in regulatory affairs , labeling , and quality… 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
