- Element Materials Technology (Acton, MA)
- …provides expert environmental monitoring and microbiology USP <797> and cGMP FDA compliance testing solutions to home infusion, pharmacies, hospital pharmacies, and ... human drug outsourcing compounding facilities. The lab is DEA and FDA registered, cGMP certified, and ISO/IEC 17025:2017 accredited **Responsibilities** + Lead and… more
- Genentech (Boston, MA)
- …standards (eg, CDISC SDTM/ADaM) + You are familiar with programming in support of regulatory submissions and compliance expectations (eg, FDA , EMA) + You bring ... for top industry talent, operating as an agile workforce to deliver regulatory commitments across the portfolio. We identify, influence, and adopt industry-leading… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized ... with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global...requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience… more
- Hologic (Marlborough, MA)
- …quality, we want to hear from you! **Knowledge:** + In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise in ... compliance issues and regulatory expectations. + Advanced knowledge of Quality Management Systems...resolution. + Collaborative mindset to work cross-functionally with R&D, Regulatory , Marketing, and Quality teams. + Proactive and adaptable… more
- Cardinal Health (Boston, MA)
- …maintains security policies and IT compliance programs in alignment with regulatory , legal, and contractual requirements, while collaborating closely with key ... IT operations, projects, and M&A activities are aligned with enterprise standards, regulatory requirements and industry's best practices. In this role, you will have… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Hologic (Marlborough, MA)
- …and validation (V&V) strategies, ensuring our software meets the highest global regulatory standards. If you're an experienced professional with a strong background ... in software engineering, regulatory compliance, and mentoring, this is your opportunity to...Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485,… more
- Takeda Pharmaceuticals (Boston, MA)
- …in pharmacovigilance by adopting new technologies for automation/intelligence while maintaining regulatory compliance. + They will play a key role as SME ... Lead E2B program expansion based on business needs and interpretation of global regulatory changes + Support MedDRA upgrade and related activities + Perform data… more
- Sanofi Group (Waltham, MA)
- …activities (when applicable), including quality, relevance to external stakeholders (eg regulatory authorities, medical journals), and scientific validity. We are an ... success. + Contribute with project team members (ie: clinical, pharmacovigilance, regulatory , ) to gain Health Authorities acceptance of the plans, accountable… more
- Charles River Laboratories (Wilmington, MA)
- …an experienced professional with expertise in establishing effective scientific and regulatory strategies to advance new medicines through the various stages of ... products. Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in… more