- J&J Family of Companies (Titusville, NJ)
- …Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** Professional **All Job ... responsible for the operational management and delivery of global clinical trial regulatory submissions . + Create and handle dossier plans/submission packages in… more
- Nestle (Bridgewater, NJ)
- …for patients and consumers. **Position Summary:** Reporting to the Head of Global Regulatory Affairs Pharma, the Regulatory Affairs Advertising, ... ensuring alignment with the overall company strategy. In collaboration with Global Regulatory Affairs leads and cross functional teams, this individual will… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- ThermoFisher Scientific (Cranbury, NJ)
- …food is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs , you will play a crucial role in interpreting ... for global requirements and desired marketing claims. + Author and/or review regulatory submissions , specifically device master files, regulatory support… more
- J&J Family of Companies (Titusville, NJ)
- …Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** People Leader **All ... way. Learn more at https://www.jnj.com/innovative-medicine We are seeking **Senior Manager , RA Submissions ** to be located Raritan,...+ Bachelor's Degree or higher in Life Sciences, Pharmacy, Regulatory Affairs , or a related field. +… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …product strategy and scientific messaging. + Collaborate cross-functionally with Medical Affairs , Regulatory , Legal, and Commercial teams to ensure consistency ... The Manager , Medical Core Content is a team-level operational...Veeva Vault, to manage content lifecycle and Medical Review submissions . + Track and report content usage and effectiveness,… more
- Eliassen Group (Trenton, NJ)
- …risk management, and communication across all stakeholders. * Coordinate with Regulatory Affairs to ensure documentation and submission readiness for ... **Project Manager , Med Device, R&D PMO, Design Changes** **Anywhere**...and industry regulatory standards. * Exposure to Regulatory submissions and Operations/manufacturing interfaces. * Background… more
- Sumitomo Pharma (Trenton, NJ)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... software + Ability to evaluate and write case reports and prepare regulatory submissions + Analytical thinking and attention to detail + Communication skills for… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... core scientific lexicon and messaging, ensuring its consistent application across all Medical Affairs materials through clear guidance to the Manager of Core… more