- Nitto Denko Corp. (Milford, MA)
- …decision-making. + Ensure site adherence to ICH, and global regulatory cGMP requirements ( FDA , EMA, MHRA, etc.). + Maintain readiness for inspections. Serve as the ... product PPQ and commercialization. + Deep understanding of international regulations such as FDA 21CFR, EU EudraLex Vol 4, USP, EP, JP. + Strong knowledge and… more
- Insight Global (Bedford, MA)
- …systems, and reporting to authorities. - Solid knowledge of medical device regulations (eg, FDA QSR, EU MDR) and standards (eg, ISO 13485, ISO 14971, IEC 62304, IEC ... Experience with AI/ML models. - Familiarity with international regulatory landscapes beyond FDA and EU MDR. - Demonstrated judgment in aligning compliance with… more
- Charles River Laboratories (Wilmington, MA)
- …industry. Working knowledge of computer validation requirements in government regulations including FDA 21 CFR Parts 11, 58, 211, and 820, OECDs, data integrity ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- Sumitomo Pharma (Boston, MA)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and NDA/MAA filings. +… more
- Cardinal Health (Boston, MA)
- …to update manufacturer knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct secondary research (eg, ... industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and approvals),… more
- Curia (Hopkinton, MA)
- …field and a minimum of 5 years of relevant work experience in an FDA -regulated pharmaceutical environment with at least 2 years in a leadership role OR Master's ... field and a minimum of 3 years of relevant work experience in an FDA -regulated pharmaceutical environment with at least 2 years in a leadership role Preferred +… more
- Merck (Boston, MA)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for this position ... Cattle, Biopharmaceuticals, Cattle Feeding, Cattle Production, Customer-Focused, Data Analysis, FDA Regulations, Feedlots, Field Sales Support, Livestock Management, Nutritional… more
- Rise Baking Company (Worcester, MA)
- …employee and consumer safety-first culture and support all guidelines of GMPs, HARPC, FDA , the Environmental Control Act, and OSHA standards to ensure safe and ... management/supervisory experience + Proficient knowledge of regulatory disciplines (EPA, OSHA, FDA , USDA) + Strong employee and consumer safety leadership experience… more
- Catalent Pharma Solutions (Chelsea, MA)
- …of International Quality and Compliance standards and requirements, with preferable FDA experience; + Demonstrated knowledge of Change management and Lean ... Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, IBM, FDA , USDA; + Ability to work under pressure to meet tight and changing deadlines;… more
- United Therapeutics (Boston, MA)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR 312 **Job Location**… more