- Takeda Pharmaceuticals (Lexington, MA)
- …deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device Clinical Strategy & Risk Management:** ... into technical requirements + Coordinate risk mitigation activities across clinical, regulatory , quality, and engineering functions + Perform safety reviews on… more
- Bristol Myers Squibb (Devens, MA)
- …a risk-based approach. **Key Responsibilities** * Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, and ... external signals, leveraging these insights to anticipate regulatory expectations, shape enterprise-wide inspection readiness strategies, and drive proactive,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA , EMA and others). * ... approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. * Represents Clinical Pharmacology in meetings with global or… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing + Advance ... + Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND / CTA, clinical sections of integrated development… more
- Oracle (Boston, MA)
- …with engineering and compliance teams to ensure process efficiency, regulatory alignment, and continuous improvement throughout the software development lifecycle ... We are looking for someone with demonstrated awareness of regulatory standards and hands-on experience integrating regulatory ...of healthcare regulations and standards relevant to software (eg FDA 21 CFR Part 820, ISO 13485:2016, EU MDR)… more
- Sanofi Group (Cambridge, MA)
- …leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, ... Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to… more
- Pfizer (Cambridge, MA)
- …contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports ... the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval. +...of clinical procedures, ICH guidelines, GCP and familiarity with FDA , EMA, and global regulations. + Extensive understanding of… more
- Takeda Pharmaceuticals (Boston, MA)
- …and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's ... your transition.** **How will you contribute:** + Ensure compliance to Regulatory Intelligence Procedures by executing the regulatory intelligence process… more
- Hologic (Marlborough, MA)
- …lifecycle. As a subject matter expert, you will partner with R&D, Regulatory Affairs, and Manufacturing Engineering teams to embed quality and compliance principles ... standards for safety, effectiveness, and innovation. **Knowledge:** + Deep expertise in FDA 21 CFR Part 820 Quality System Regulation, ISO 13485, ISO 14971:2019… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA , EMA and others). + ... approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or… more