- Takeda Pharmaceuticals (Cambridge, MA)
- …chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs , to develop and implement effective process ... or business processes. + Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs),… 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
- Sanofi Group (Cambridge, MA)
- …qualified with: + Min 15 years of experience working in clinical development and/or regulatory affairs + Min 10 years of leading an internationally dispersed ... of sanofi revenues by expediting submission timelines and facilitating reviews by regulatory agencies of sanofi key assets. + He/she: Creates and executes a… more
- Takeda Pharmaceuticals (Boston, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, ... Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies. + Must have experience in global regulatory … more
- AIG (Boston, MA)
- …you need a reasonable accommodation, please send an email to ###@aig.com. Functional Area: LG - Legal, Regulatory & Gov't Affairs AIG PC Global Services, Inc. ... strategies to insurance executives and underwriters with respect to transactional, regulatory , legal and compliance matters impacting the business objectives of the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …interacting with senior internal and external personnel. Provide validation expertise to regulatory affairs when responding to governmental regulatory ... bodies. Up to 5% domestic travel required. Up to 40% remote work allowed. **REQUIREMENTS:** Bachelor's degree in Industrial Chemical Engineering, Chemical Engineering, or related field, plus 7 years of related experience. Prior experience must include: prepare… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director May… more
- Eversource Energy (Westwood, MA)
- …cross\-functional teams including System Planning, Engineering, Siting, Real Estate, Legal, Engagement, Regulatory Affairs , and more + Ensures that all strategic ... Strategic Projects + Assists with representing Eversource Transmission at public meetings, regulatory hearings, town hall meetings and any special meetings that may… more
- Beth Israel Lahey Health (Plymouth, MA)
- …conflict resolution + Prior experience in direct responsibility for regulatory affairs and claims management strongly preferred **Registration/Certification:** ... Massachusetts DPH, the Boards of Registration in Medicine and Nursing, and other regulatory agencies as needed. In particular lead the investigation and response to… more
- Eversource Energy (Westwood, MA)
- …\(5\+ year\) range distribution plans\. + Supports the community relations and regulatory affairs teams for clear communications on the Company's electrification ... status reports\. + Supports any related documentation and/or testimony to support regulatory filings\. + Presents recommendations and/or results to all levels of… more