- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory … more
- Stryker (Mahwah, NJ)
- ** Senior Manager , Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the ** Senior Manager , Regulatory ... new product launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time… 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
- Pentax Medical (Montvale, NJ)
- …provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are ... in shaping the future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist :...biocompatibility requirements + Proven track record in writing major regulatory device submissions (ie 510(k)s), with the… more
- Ascendis Pharma (Princeton, NJ)
- … Regulatory Project Manager will be an integral part of Global Regulatory Affairs , providing project management leadership to key global regulatory ... the Ascendis pipeline. As a part of the Global Regulatory Affairs team, you will be responsible...in the end-to-end planning, coordination, and execution of assigned Regulatory submissions project deliverables. + Monitor submission… more
- Oracle (Trenton, NJ)
- …with senior design leads + Provide QA/QC on design submissions and support compliance with Oracle's documentation standards + Participate in internal ... center infrastructure. You will work under the direction of senior team members and collaborate closely with OCI's engineering,...in architecture, Engineering, or related technical discipline; PE or RA license is a plus + 4+ years of… more