- Nitto Denko Corp. (Milford, MA)
- …CAPAs, Batch Records, and associated GMP documentation to ensure compliance with applicable regulatory standards ( FDA , EMA, ICH). This role serves as a Subject ... in accordance with document lifecycle procedures. + Maintain compliance with applicable regulatory and company documentation standards. + Represent QA in QA Group,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …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
- Cambrex High Point (Waltham, MA)
- …tests. + Strong working knowledge of GMP requirements, ICH guidelines, and regulatory expectations ( FDA , EMA). + Experience in quality control testing, ... etc. to characterize and quantitate pharmaceutical synthetic molecules. Knowledge of regulatory guidelines and experience in quality control testing are preferred.… more
- Cytel (Cambridge, MA)
- …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
- AbbVie (Worcester, MA)
- …SCADA, and Data Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions ... responsible to provide the necessary support during the internal and external regulatory audits. Qualifications + Bachelor's degree in computer science or related… more
- Nitto Denko Corp. (Milford, MA)
- …to cross-functional decision-making. + Ensure site adherence to ICH, and global regulatory cGMP requirements ( FDA , EMA, MHRA, etc.). + Maintain readiness ... you will report to the VP of Quality and Regulatory Affairs. The role is responsible for leading and...commercialization. + Deep understanding of international regulations such as FDA 21CFR, EU EudraLex Vol 4, USP, EP, JP.… more
- AbbVie (Worcester, MA)
- …connected, accurate, secure and in full compliance with AbbVie's global program and regulatory standards including FDA , EMA and MHRA requirements. This role ... inspections related to data integrity. + Ensure adherence to regulatory standards (e, g FDA , GxP etc.)...Ensure adherence to regulatory standards (e, g FDA , GxP etc.) + Manage remediation efforts, utilizing risk… more
- Insight Global (Bedford, MA)
- …a risk-based approach. - Experience with AI/ML models. - Familiarity with international regulatory landscapes beyond FDA and EU MDR. - Demonstrated judgment in ... and failure analysis. Collaborate cross-functionally (eg, with R&D, Marketing, Regulatory ) to drive CAPAs. Potentially supervise others and lead quality-focused… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and… more
- Takeda Pharmaceuticals (Boston, MA)
- …standard macros that can be adapted to multiple studies; Prepare deliverables for regulatory submission to FDA /EMA/PMDA or other agencies (eg eCRTs, ISS, ISE, ... medical terminology, clinical trial methodologies to ensure the compliance with regulatory agencies and data reporting standards; create and review specifications… more