- WM (Foxborough, MA)
- …to facility permitting and development projects, public sector contracts, government and regulatory affairs , and the management of commercial and regulatory ... litigation matters as necessary through the assistance of outside counsel. Legal support provided by this position will be focused primarily on moderate to large, complex commercial/business matters. The position will contribute to and interact with staff… more
- 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
- Sanofi Group (Cambridge, MA)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first in class and best… 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
- Astellas Pharma (Cambridge, MA)
- …enterprise objectives. -Play a strategic lead role, in collaboration with Research, Regulatory Affairs and Early Development and Translational Sciences, to ... and managing strong alliances with the Oncology Research, medical affairs , commercial and business development organizations to enable end-to-end execution.… 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 ... including Applied Research, New Product Development, Marketing, Medical and Clinical Affairs , Market Access, and External Innovation, to develop technologies that… more
- Cole-Parmer (Franklin, MA)
- …product line development in collaboration with Research & Development, Operations, Regulatory Affairs and Commercial teams. Implement appropriate programs to ... either internally develop, contract manufacture, license or source the appropriate products with the goal of driving revenue & profitability growth of the category portfolio. + Drive product area efforts and coordinate with Corporate Development (M&A) and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …brand objectives. Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to help anticipate, ... We are seeking a Senior Director, Federal Government Affairs to lead our US federal government engagement...for in a multitude of public policy, legislative, and regulatory regimes and initiatives. Key Responsibilities Serve as the… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies and optimize ... process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification… 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