- Sumitomo Pharma (Trenton, NJ)
- …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... of external publishing staff contracted to publish and dispatch health authority submissions . + Represents Regulatory Operations on project teams for matters… more
- System One (Florham Park, NJ)
- … information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions . + Maintain knowledge of local regulatory ... DMF). + Ensure consistency across regulatory submission documents following the regulatory style guide (ie formatting, reviewing, and submissions ). + Provide… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …**Preferred Qualifications:** + Demonstrated success in the preparation and completion of regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other ... changes and line extensions. The incumbent may also develop and implement regulatory strategies to support new 510(k) submissions , CE marking applications,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … Affairs Specialist assists in the preparation, review and submission of high quality, regulatory submissions such to the Food and Drug Administration (FDA) and ... The Regulatory Affairs Specialist, assists in the management of regulatory submissions to (FDA) and other Health Authorities, as required, within company… 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 ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent ... regulatory authorities. You will oversee preparation and maintenance of regulatory submissions , regulatory labeling and packaging for assigned products or… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …the scope of experimentation and the selection of data needed to support regulatory submissions . + Interacts with regulatory authorities regarding programs ... and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …compliance. They participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions , interact with ... labeling in consideration of US, EU, and other global regulatory requirements. + Authors FDA submissions , EU technical files, and other regulatory documents… more
- Merck (Rahway, NJ)
- …systems and tools that enable planning, execution, and analysis/reporting of regulatory submissions **Desired Experience, Education & Skills:** + Advanced ... Regulatory Labeling, Regulatory Management, Regulatory Operations, Regulatory Strategies, Regulatory Submissions , Strategic Initiative {+ 5 more}… more
- Organon & Co. (Jersey City, NJ)
- …on assigned products for all internal and external stakeholders to ensure timely regulatory submissions , quality and compliant labeling documents, and to support ... with local country affiliate colleagues to support timely and quality regulatory submissions and approvals globally. **Required Education, Experience and… more