- Bausch Health (Bridgewater, NJ)
- …Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions + Coordinate with ... Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory contact with Regulatory Authorities for… more
- Bausch Health (Bridgewater, NJ)
- … compliance. + Active member of product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions + Coordinate with ... Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Manage interactions with other BHC functions (eg, Quality,… more
- Bank of America (Jersey City, NJ)
- …for local Banks, Broker Dealers and other legal entities, prepares/reviews data submissions for regulatory reporting teams. The Regulatory Reporting ... performing and documenting control processes, and the preparation of data submissions for regulatory reporting teams. **Responsibilities:** This job is… more
- Organon & Co. (Jersey City, NJ)
- …follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions . + Conduct Regulatory review and final approval of all ... **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, Global… more
- Bausch Health (Bridgewater, NJ)
- …execution, and reporting of clinical studies, with a strong focus on regulatory submissions , including New Drug Applications (NDAs). This position requires ... execution, and data interpretation. + Author, review, and contribute to regulatory submissions , including NDAs, BLAs, MAAs, INDs, and briefing documents. +… more
- Bristol Myers Squibb (Summit, NJ)
- …and translational data generated to support asset development and contribute to regulatory submissions . This individual will work on cross-functional project ... written documents such as primary manuscripts/publications/reviews, scientific presentations and regulatory submissions (INDs/NDAs) with ability to synthesize… more
- Sanofi Group (Morristown, NJ)
- …generation for reports leading to the authoring of CMC dossier content for regulatory submissions and quality documentation. This is conducted ensuring alignment ... authoring, development, and review of CMC dossiers (Modules 2 and 3) for regulatory submissions including, but not limited to, INDs, NDAs, IMPDs, and MAAs in… more
- Merck (Rahway, NJ)
- …applied to designing and analyzing clinical trials in support of worldwide regulatory submissions . This position involves interaction with Medical, Data ... Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions , Scientific Modeling,… more
- SMBC (Jersey City, NJ)
- …based on back-testing outcomes, sensitivity analyses, and new data trends. + Support regulatory submissions and address feedback from examiners (eg, FRB, OCC) ** ... CECL accounting standards and Basel III/IV capital adequacy requirements. + Support regulatory submissions and address feedback from examiners (eg, FRB, OCC).… more
- Sanofi Group (Morristown, NJ)
- …be leading and overseeing all statistical work for clinical development and regulatory submissions , leading a team focused on clinical development strategies, ... and competencies in clinical development or post-marketing activities such as submissions , interactions with regulatory agencies (including NDA/BLA and EMA… more