- Norstella (Trenton, NJ)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... therapeutic research and industry trend analysis, including competitive positioning, regulatory changes, domain-specific insights, and opportunities + Drive innovation… more
- Colgate-Palmolive (Piscataway, NJ)
- …Knowledge of Regulatory environment across the globe + Knowledge of ICH/ FDA guidelines for stability and testing of new drug products **Compensation and ... high-quality commercialization. + Maintain all required documentation under **GMP/GLP** per FDA /ICH guidelines as required. + Documentation may include R&D project… more
- Integra LifeSciences (Plainsboro, NJ)
- …perform all duties in accordance with the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the ... other applicable regulatory agencies. **This is for a Weekend Lead, the...the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred.… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and work closely with key members of internal departments including, Legal, Regulatory Affairs, Marketing, Global Health Economics, Value and Outcomes (Global HEVO), ... This review is done in collaboration with Legal and Regulatory members (PARC, Promotional Advertising Review Committee) to ensure...materials, etc.) meet the US Food and Drug Administration ( FDA ) Code of Regulations and guidance documents, as well… more
- Integra LifeSciences (Plainsboro, NJ)
- …Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements. + Participate in FDA inspections, ISO ... the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies. **Primary responsibilities are:** **(Validations, Risk Management and… more
- Oracle (Trenton, NJ)
- …with engineering and compliance teams to ensure process efficiency, regulatory alignment, and continuous improvement throughout the software development lifecycle ... We are looking for someone with demonstrated awareness of regulatory standards and hands-on experience integrating regulatory ...of healthcare regulations and standards relevant to software (eg FDA 21 CFR Part 820, ISO 13485:2016, EU MDR)… more
- Terumo Medical Corporation (Somerset, NJ)
- …the organization that includes Medical Affairs, Clinical Operations, Sales, Marketing, Regulatory Affairs, to ensure maximum exchange of information and insights. ... business partners. + Conduct all activities in accordance with current regulatory and health care compliance guidelines. + Provide high-level research support… more
- Sanofi Group (Morristown, NJ)
- …leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, ... Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to… more
- Merck (Rahway, NJ)
- …Maintain training materials in compliance with applicable SOPs, policies, and regulatory requirements. + Defines and contributes to the development of training ... trial processes, including relevant standards and documentation. + Familiarity with FDA Good Clinical Practices, ICH Guidelines, and other major regulatory… more
- Roche (Branchburg, NJ)
- …in the technical writing series, providing strategic leadership and definitive regulatory guidance for all documentation projects. Your responsibilities will include ... resource for ensuring content quality and strict adherence to global regulatory requirements. **The Opportunity** People Leadership + **Supervise** direct reports,… more