- Merck (Boston, MA)
- …+ Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide ... + Local registration study protocols for secondary markets + Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide… more
- ConvaTec (Lexington, MA)
- …project work + **Scientific & Technical Labs** to execute testing, as required. + ** Regulatory Affairs ** to collaborate on requirements as well as gain early ... Applied Research organization within the Biomedical Sciences team, the Principle Scientist - Biointerfaces and Regenerative Engineering is responsible for leading a… 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 ... to shine? Join us as a PV Risk Management Scientist /Associate Director. At Takeda, we are transforming the pharmaceutical...we do. As an Associate Director/ PV Risk Management Scientist , being part of our Risk Management and Benefit… 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
- Sanofi Group (Cambridge, MA)
- …The GPH will be delegated such responsibilities as interaction with regulatory /health authorities (HA), approval of documents and product label, as appropriate. ... Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the...close collaboration with Market Access, Global Commercial and Medical Affairs , as Active member of GPT. + Contributor to… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to work… 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)
- …Development Team but more likely will oversee the study physician and/or clinical scientist leads responsible for leading the team. Emphasis will be on insuring that ... development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency… more