- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... and all other applicable laws, regulations, and standards. **Qualifications** Experience: + Minimum five (5) years previous service-related experience. + Demonstrated ability at operating installation tools and test equipment. + Extensive knowledge and… more
- J&J Family of Companies (New Brunswick, NJ)
- …for marketing authorization approvals (label expansions and initial approvals) by the US FDA , as well as regulatory authorities in the EU, Asia Pacific ... and epidemiologic research to support post-market safety and effectiveness, regulatory submissions, product development, product launches, value assessments, predictive… more
- CVS Health (Parsippany, NJ)
- …reviewing product labels, marketing claims, and promotional campaigns to ensure legal and regulatory compliance with FDA and FTC requirements, as applicable. + ... and business objectives. You will be primarily responsible for the legal and regulatory review of new and innovative products, from concept inception, regulatory … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- embecta (Parsippany, NJ)
- …that all quality systems and operations comply with internal standards and regulatory requirements, including FDA and ISO standards. The Quality Compliance ... fostering a culture of continuous improvement while driving adherence to quality and regulatory expectations across the organization. This role will be hybrid 2 days… more
- System One (Cranbury, NJ)
- …utilities qualifications. All activities will be performed in compliance with cGMP, FDA , and other applicable regulatory standards. Responsibilities: + Perform ... a safe working environment in accordance with company policy and regulatory requirements. + Support third-party validation activities as applicable. + Complete… more
- Cytel (Trenton, NJ)
- …motivate a strong team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development ... model-informed drug development), to provide strategic advice to define optimal regulatory , clinical and/or market access pathways and promote faster patient access… more
- J&J Family of Companies (Raritan, NJ)
- … and clinical requirements for diagnostics development and commercialization, including global regulatory frameworks (eg, FDA , EMEA, PMDA). + Proven ability to ... all assets within Heme, ensuring alignment with overall clinical development and regulatory activities. + Serve as the primary point of accountability for diagnostic… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director, Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... communication to support both internal and external customers (globally) including the US FDA . Job Responsibilities Note: These statements are not intended to be an… more
- Mondelez International (East Hanover, NJ)
- …+ Evaluate adherence to internal quality standards (eg, OQS, SQE) and external regulatory requirements (eg, FDA ). + Review corrective and preventive actions ... and partner with cross-functional internal and external business partners (R&D, regulatory , marketing and manufacturing) to meet our quality agenda. In addition,… more