- 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
- Edwards Lifesciences (Trenton, NJ)
- …and healthier lives. Join us and be part of our inspiring journey. The Senior Manager , Medical Writing oversees medical writing projects and team operations in ... oversee the work of small medical writing team to support clinical and regulatory submissions (eg, clinical study reports, clinical evaluation reports) and may… 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