- 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
- Meta (New York, NY)
- **Summary:** We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a ... wrist wearables, and other innovative devices. **Required Skills:** Medical Devices, Regulatory Affairs Specialist Responsibilities: 1. Interact directly with… more
- Mount Sinai Health System (New York, NY)
- …or health care policy. + A minimum of 5 years of research experience in Regulatory Affairs , Clinical Affairs or Quality Assurance with knowledge of Phase ... event forms, etc. + Collaborates with the Clinical Trials Manager in developing and ensuring clinical trial regulatory...submissions as required. + Collaborates with the Financial Manager on the development of the study budget (as… 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
- Mount Sinai Health System (New York, NY)
- …The Regulatory Project Coordinator will be responsible for supporting the regulatory affairs team in managing and coordinating regulatory projects. ... consent forms, site-specificregulatory packets). + Collect, organize, and assemble regulatory submissions , including FDA 1572 Forms, financial disclosure… 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
- Merck (West Point, PA)
- …biologics and vaccines. The role also requires extensive engagement with Manufacturing, QA, Regulatory Affairs , and Supply Chain. The ideal candidate should have ... + Implement/maintain LIMS, ELN, and analytics for decision-making and regulatory submissions . + Represent BCR in executive...biologics. Must have at least 5 years as a manager in a supply focused team (ie critical reagents,… more