- Grifols Shared Services North America, Inc (Worcester, MA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
- Danaher Corporation (Boston, MA)
- …or PhD in a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. ... m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for regulatory strategy… more
- Rhythm Pharmaceuticals (Boston, MA)
- …team, you'll be responsible for the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards ... timelines + Ensure effective and timely execution of regulatory filings in compliance with relevant ...orphan products, fast track, breakthrough therapies, PRIME) + Strong FDA and EMA experience required + Full functional knowledge… more
- Pfizer (Cambridge, MA)
- …responsible for developing and executing global (Influenza/COVID-19) and US (COVID-19) regulatory strategies and ensuring compliance with applicable regulations. ... Regulatory and Cross-functional teams, managing submissions, and interacting with Regulatory agencies worldwide (Influenza/COVID-19) or the US FDA (COVID-19).… more
- Takeda Pharmaceuticals (Boston, MA)
- …of global cross-functional teams which require experienced interpretation of applicable EMA/ FDA /ICH/WHO/Global regulations to ensure CMC compliance within the ... GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member on … more
- Sanofi Group (Cambridge, MA)
- …consistency between core and local market labeling; collaborate with regional /country regulatory teams to address labeling implementation or compliance issues. ... on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Management:** Establish and maintain data integrity policies, procedures, and guidelines. Ensure compliance with regulatory requirements (eg, FDA , EMA) and ... **Global Systems:** Manage and optimize global Quality systems to ensure compliance , efficiency, and continuous improvement. Establish and maintain best practices… more
- Teleflex (Chelmsford, MA)
- …the development, implementation, and maintenance of the quality management system (QMS) in compliance with regulatory requirements (eg, FDA , ISO 13485). ... change control within Global and Legacy Agile systems *Promote compliance through effective change management, document retention policies, Good Documentation… more
- Takeda Pharmaceuticals (Boston, MA)
- …you and empower you to shine? Join us as a Manager, Global Trade Compliance based in Cambridge/Lexington, MA reporting to the Senior Director - Global Clinical ... Supply Chain Import Export Operations and Global Trade Compliance . At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market… more
- Takeda Pharmaceuticals (Boston, MA)
- …to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality ... is available to support your transition.** **How will you contribute:** + Ensure compliance to Regulatory Intelligence Procedures by executing the regulatory … more