- 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
- 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
- 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