- Cipla (Hauppauge, NY)
- …that products, equipment, and systems meet all applicable safety, quality, and regulatory requirements. They do this by developing and implementing validation plans, ... Part 11 compliance. Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU/MHRA data… more
- Cipla (Fall River, MA)
- …operations for compliance to cGMP and set standards to meet the regulatory requirement and to ensure audit readiness. Ensure proper receipt, verification, ... instructions and document results. Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment highly preferred. Basic… more
- Sonora Quest Laboratories (Phoenix, AZ)
- …subset testing while serving as a trusted resource for quality, compliance, and regulatory excellence. This is your chance to collaborate with a skilled team, solve ... assisting with department compliance with all pertinent laboratory accrediting agency and regulatory requirements (eg, CLIA '88, JCAHO, CAP, OSHA). This position is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls and maintain permanent inspection readiness and actively support regulatory inspections.Ensure investigations are processing timely according to site ... rationales, and approval for engineering and process changes to meet regulatory requirements.Work closely with cross-functional teams to design and implement cell… more
- Formation Bio (New York, NY)
- …evaluation to pre-close. Coordinate cross-functional workstreams (Clinical, CMC, Regulatory , Nonclinical, QA, Commercial, Finance, Legal/IP). Maintain trackers, RAID ... preferred. Familiarity with term sheets, diligence workplans, asset integration, and regulatory /quality transitions a plus. Formation Bio is prioritizing hiring in… more
- Repligen (Waltham, MA)
- …technology solutions comply with GMP (Good Manufacturing Processes) and other regulatory requirements.Partner with process owners to optimize SAP and other ... SAP, QMS, MES, PLM, or similar systems.Expertise in GMP and regulatory requirements in bioprocessing.Experience leading or supporting AI, automation, or data… more
- Stellantis Financial Services US (Houston, TX)
- …relationships with industry peers to stay informed about trends and potential regulatory changes. Join our team to leverage your expertise in managing repossession ... and maintain industry relationships to stay informed about trends and regulatory changes. Advanced Excel skills Intermediate MS Office skills (PowerPoint, Word,… more
- Stellantis (Auburn Hills, MI)
- …cause analysis and more importantly systemic corrective actions tied to safety and regulatory recalls all within a defined closure timing with exceptional detail to ... development, ensuring timely completion and alignment with internal standards and regulatory expectations (eg, FMVSS, EU ECE). Validate that corrective actions are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and ... serving as an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with… more
- Insmed Incorporated (NJ)
- …xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs, drug development, FDA and regulatory guidelines (ie, PhRMA ... guidelines, OIG, AMA, ACCME, Sunshine Act, etc.)Global mindset with understanding of US, European, and Japanese marketsForward looking with continuous process improvement mentalityStrong strategic thinking with ability to connect multiple componentsStrong… more
