- Sokol Materials & Services (Skillman, NJ)
- …facility qualification. + Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA , EMA, and ICH guidelines. ... service providers, you will ensure that critical CQV activities align with regulatory standards and best practices. This role requires a professional with analytical… more
- Astrix Technology (New Brunswick, NJ)
- …with preparing regulatory submissions and data packages for interactions with regulatory agencies (eg, FDA ). This job description is a complete list ... + Ensure compliance with cGMP regulations, quality systems, and applicable ICH/ regulatory guidelines. + Participate in the investigation and documentation of… more
- Cytel (Trenton, NJ)
- …with Bayesian methods preferred. + Ensure quality and compliance with internal standards and regulatory guidelines (eg, FDA , EMA, ICH). **Here at Cytel we want ... complex manufacturing data to ensure product quality, consistency, and regulatory compliance. **As a Principal Biostatistician, your responsibilities will include:**… more
- Innovation Foods LLC (Millville, NJ)
- …documentation for all internal and government requirements. Act as a liaison for regulatory compliance agencies (USDA, FDA , Kosher, Halal, and others) Coach and ... to the General Manager, is tasked with leading all Food Safety, Regulatory , Sanitation, and Product Quality activities. The Director of Quality works closely… more
- Hovione (East Windsor, NJ)
- …and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines ... and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications. - In the early… more
- ARUNDEL MACHINE (Emerson, NJ)
- …or reworks as needed + Ensure the company's products comply with all FDA regulations, prepare submissions and maintain regulatory databases + Adhere strictly ... to all CGMP, FDA 21 CFR820, ISO 13485, EU MDR and company procedures to ensure the quality and integrity of the products and safety of the workplace + Keep Quality area organized and clean + Keep stock of Quality materials such as tip protectors, test… more
- Astrix Technology (Monmouth County, NJ)
- …evaluation and benefit-risk assessment reports + Ensure all documents are compliant with regulatory guidelines (ICH, EMA, FDA , etc.), internal SOPs, and quality ... standards. + Collaborate with cross-functional teams including drug safety, regulatory affairs, clinical development, and biostatistics. + Interpret and synthesize… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …education regarding customer complaint processing, MDR's, complaint report ability, and regulatory compliance. + Fills out decision trees when needed, after ... reviews and approves. + Generates MDR reports in accordance with BD procedures and FDA regulations. **To be successful in this role, you should be able to… more
- Bristol Myers Squibb (Princeton, NJ)
- …key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards, and drives the strategy and execution ... optimize product benefit-risk profiles. The ED works cross-functionally with clinical, regulatory , medical affairs, quality, and commercial teams to support the safe… more
- J&J Family of Companies (Titusville, NJ)
- …quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, ... reports and for the preparation and approval of essential documents for regulatory filings. + Working with functional partners responsible for the clinical… more