- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Rhythm Pharmaceuticals (Boston, MA)
- …of eCTD submission-ready documents, coordinating across functions, and ensuring quality , accuracy, and adherence to regulatory guidelines. Additionally, ... (SOPs) quality assurance, and records management practices related to regulatory operations activities + Track regulatory department information such as… more
- Sanofi Group (Cambridge, MA)
- …on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...consideration of patient experience data (eg, Patient Report Outcomes, quality of life measures). This strategic input ensures alignment… more
- Takeda Pharmaceuticals (Boston, MA)
- …in compliance with global regulations (eg, GxP, 21 CFR Part 11, ICH, EMA, FDA , PMDA) and Takeda's quality and risk management standards. + Work closely ... Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across...with architecture, engineering, quality , and data teams to ensure scalable and interoperable… more
- 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...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape the ... In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and… more
- ThermoFisher Scientific (Boston, MA)
- …digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities ... full-time benefits. **Key responsibilities:** + Support preparation of global regulatory submission sections, for late-stage and commercial programs in analytical… more
- Nitto Denko Corp. (Milford, MA)
- …As the Site Head of Quality Assurance, you will report to the VP of Quality and Regulatory Affairs. The role is responsible for leading and managing all QA ... functions at the Cincinnati site to ensure compliance with regulatory standards, internal quality policies, and customer...decision-making. + Ensure site adherence to ICH, and global regulatory cGMP requirements ( FDA , EMA, MHRA, etc.).… more
- Cambrex High Point (Waltham, MA)
- …working knowledge of GMP requirements, ICH guidelines, and regulatory expectations ( FDA , EMA). + Experience in quality control testing, stability programs, ... analyzer etc. to characterize and quantitate pharmaceutical synthetic molecules. Knowledge of regulatory guidelines and experience in quality control testing are… more