- Catalent Pharma Solutions (Chelsea, MA)
- …of final products. **EDUCATION AND** **EXPERIENCE** : Requires a Bachelor's degree in Drug Regulatory Affairs and 4 years of experience in job offered or 4 ... Perform various quality assurance checks during all manufacturing processes; Assess regulatory and quality risks in manufacturing activities and processes according… more
- Baystate Health (Springfield, MA)
- …and Regulatory Compliance** + Collaborates with the VP, Safety and Regulatory Affairs , to ensure hospital compliance with The Joint Commission, CMS ... to optimize performance on mandated state, federal or commercial payor funded, or regulatory metrics or other local quality reporting as required due to specialized… more
- Takeda Pharmaceuticals (Boston, MA)
- …assessment document + Engages with partner global functions (eg Clinical Science, Med Affairs , Regulatory Affairs , Biostats) to ensure alignment of global ... position for pharmacovigilance risk management processes to maximize patient safety + Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing. + ... Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development… more
- Astrix Technology (Boston, MA)
- …+ Collaborate with cross-functional teams, including preclinical, clinical operations, and regulatory affairs , to integrate and execute clinical strategy. + ... including RNA, genomic, proteomic, and imaging-based markers. + Contribute to global regulatory submissions (eg, INDs, CTAs) and provide medical input in alignment… more
- Amgen (Cambridge, MA)
- …closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs , to ensure alignment and successful design transfer. ... deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key Responsibilities: + **Design Transfer Execution:** Develop and… more
- Takeda Pharmaceuticals (Boston, MA)
- …remote work allowed with 5 days/month onsite. **REQUIREMENTS:** Master's degree in Regulatory Affairs , Pharmacy, Biochemistry, Biology, or science related field ... (PEARL) to generate trending tables that are utilized in regulatory filings described below; Verify GMP test data meets...Systems such as MEDIVA and VEEVA; Author sections of regulatory dossiers for clinical trials (including specific areas of… more
- Highmark Health (Boston, MA)
- …position serves as a key liaison between Claims Operations, Customer Service, Regulatory Affairs , IT, Legal and other departments, proactively identifying, ... assessing, and mitigating compliance risks. The Analyst will monitor regulatory changes, interpret their impact on operational processes, and implement effective… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing + ... Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development… more
- AbbVie (Worcester, MA)
- …guidelines. + Experience collaborating with the process development, quality control, and regulatory affairs teams to align analytical strategies with project ... guidelines, ensuring methods are suitable for late-phase development and regulatory submissions. + Experience using automation to standardize high-throughput… more