- Ascendis Pharma (Princeton, NJ)
- …(Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert knowledge of FDA safety regulations, ICH ... create Corrective Action and Preventative action (CAPA) as applicable. + Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- Ascendis Pharma (Princeton, NJ)
- …launch of an investigational treatment for hypoparathyroidism currently under review by the FDA . This role requires the ability to be both strategic and tactical, ... to renewal and termination. Ensure compliance with company policies, regulatory requirements, and contractual obligations. Expectations in this role include… more
- Penn Medicine (Cherry Hill, NJ)
- … Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... to emergency/code situations. + CCA MAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- System One (Piscataway, NJ)
- …molecule and biosimilar products. Candidates must bring strong GMP and regulatory knowledge, with expertise in protein chemistry and analytical troubleshooting. If ... + Document results in compliance with GMP, ICH, and FDA standards + Author and revise SOPs, QC methods,...summaries + Support batch release, batch record reviews, and regulatory dossier preparation + Lead and/or support laboratory investigations,… more
- Sanofi Group (Morristown, NJ)
- …strategy and the network of collaborators from preclinical research to operational, regulatory , and commercial functions. Success in this role requires the ability ... of responsibility. The GPH will be responsible for interaction with regulatory authorities, approval of protocols, informed consent documents, clinical study… more
- Penn Medicine (Woodbury Heights, NJ)
- …/ Regulatory : Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... to emergency/code situations. CCA CSAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines reads… more
- Sanofi Group (Morristown, NJ)
- …for submission to regulatory agencies, including but not limited to the FDA and EMA + Prepare abstracts, posters and manuscripts for external presentation and/or ... potential drug-drug interactions, quantifying benefit-risk relationships, and contributing to regulatory submissions and interactions from first-in-human studies through life-cycle… more
- Penn Medicine (Cherry Hill, NJ)
- … Regulatory : . Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... to emergency/code situations. . CCA MAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Penn Medicine (Woodbury Heights, NJ)
- …/ Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... to emergency/code situations. + CCA CSAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …external partners, and quality systems for ensuring compliance with regulatory requirements and expectations, standards, industry trends, and regulatory ... company policies and procedures. The role involves supporting readiness for regulatory inspection and collaborating across the regional organization to participate… more