- AbbVie (Cambridge, MA)
- …drug substance and drug product development. + Experience developing global regulatory strategies including authoring regulatory submissions, and responding to ... position involves multi-disciplinary collaborations across Discovery, Development, Manufacturing, and Regulatory to execute and deliver material and information for… more
- Pfizer (Cambridge, MA)
- …contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports ... understanding of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-Clinical, Pharmacology, Quality Assurance. + Experience… more
- AbbVie (Worcester, MA)
- …guidelines, ensuring methods are suitable for late-phase development and regulatory submissions. + Experience using automation to standardize high-throughput ... + Familiarity with statistical tools for data analysis, Empower and regulatory guidelines. + Experience collaborating with the process development, quality control,… more
- Stantec (MA)
- …in New England and the eastern US. **Your Key Responsibilities** + Regulatory proficiency to provide technical support on environmental site investigations and ... submittal of regular monitoring reports, remedial action plans, and various regulatory program permit applications + Providing on-site support at client facilities… more
- ThermoFisher Scientific (Boston, MA)
- …technical documents, including method SOP, study protocol, technical report, and other regulatory agency facing documents + Be a key Subject Matter Expertise (SME) ... Skills and Abilities:** **Must Have** + Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concepts + Excellent technical writing… more
- Nanobiosym, Inc. (Cambridge, MA)
- …manner through successful FDA submission + Manage and contribute to regulatory documents + Project management; personnel management skills preferred + Design ... expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience + Demonstrated experience and… more
- Bristol Myers Squibb (Cambridge, MA)
- …+ Participate in the preparation of technical reports, summaries, protocols, and regulatory documents, where necessary. + **MAJOR SKILLS REQUIRED:** + BS in a ... scientific discipline and at least 5 years of relevant laboratory experience or MS with at least 3 years of relevant experience preferred. + Protein purification experience including method development, optimization, and the ability to troubleshoot standard… more
- ThermoFisher Scientific (Boston, MA)
- …Gene and Cell therapy is desirable + Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept + Experience with analytical support ... for late-stage or commercial biological products and cGMP manufacturing + Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency + Partners effectively with internal and external… more
- Stantec (Boston, MA)
- …This core group consists of a diverse team of environmental and regulatory specialists in Massachusetts and throughout New England. Our Northeast Environmental ... Services team includes a deep bench of staff with diverse technical capabilities, who embrace the company culture of collaboration. It is a great place to work, learn, and grow your career. We are seeking to build a pool of talented individuals. Upon… more
- Deloitte (Boston, MA)
- …IT teams to integrate AI workflows. + Collaborate with legal teams to meet regulatory standards for tax data. + Perform model audits to identify and mitigate risks. ... + Monitor and optimize generative models for performance and scalability. The Team Deloitte Tax LLP's Tax Transformation Office (TTO) is responsible for the design, development, and deployment of innovative, enterprise technology, tools, and standard processes… more