- Fresenius Medical Center (Waltham, MA)
- …be fully remote . **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product ... compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for… more
- J&J Family of Companies (Boston, MA)
- Senior Regulatory Affairs Specialist - 2406193618W **Description** Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory ... has a proven track record for growth, integrity and innovation. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to… more
- Harvard University (Cambridge, MA)
- …protected by law.Job Summary:The Senior Manager for Intergovernmental Policy and Regulatory Affairs for Harvard Public Affairs and Communications (HPAC) ... and its operations. The Senior Manager for Intergovernmental Policy and Regulatory Affairs brings significant knowledge of state and municipal regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Manager, Regulatory Affairs Project Management and Strategic Planning ... through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global ...around the world. This position is currently classified as " remote " in accordance with Takeda's Hybrid and Remote… more
- Beth Israel Lahey Health (Boston, MA)
- …+ Bachelor's degree in Life Science or related field required; Master's degree in Regulatory Affairs preferred. + Minimum of 3-5 years related work experience ... 32 **Work Shift:** Rotating (United States of America) The Sr . Regulatory Specialist supports regulatory ...Center (BIDMC). The position is flexible in terms of remote versus onsite work. A part-time opportunity is available.… more
- Merck (Boston, MA)
- **Job Description** The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs ... model to maintain best-in-industry regulatory compliance. The Vice President Regulatory Affairs , General Medicine is accountable for: + Directing and… more
- Takeda Pharmaceuticals (Boston, MA)
- …alignment for other medium and/or high complexity products. Interface with Senior Management Cross-Functional Team (GLOC) + Coordinates the process to obtain ... labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) and facilitates discussions to ensure… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... date on the latest global regulations. + Collaborate closely with the Quality, Regulatory , R&D, Business Development, Medical & Scientific Affairs , IT, and… more
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in early and ... ** Regulatory Strategist** + Location: Cambridge, MA + Remote Work: Hybrid + Job Type: Full Time **About...regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed. + May lead Health Authority… more
- Takeda Pharmaceuticals (Boston, MA)
- … management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive Director and ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, GRA - CMC Pharmaceuticals- Small Molecule where...Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will… more
- Amgen (Cambridge, MA)
- …peers across Amgen's internal network (eg, Process Development, Manufacturing, Quality, Regulatory Affairs ) and external suppliers, to ensure uninterrupted ... alongside other innovative, driven professionals in this meaningful role. **Process Development Senior Scientist** **Live** **What you will do** Let's do this! Let's… more
- Bristol Myers Squibb (Boston, MA)
- …child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. **\#LI- Remote , # BMSNEURO** If you come across a role that ... . Reporting into the Medical Value Liaison Field Director, the Senior Medical Value Liaison (MVL)/Executive MVL is a field-based role focused… 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) ... our core values by staying **True to Life.** **Job Description** The Senior Supplier Quality Engineer is responsible for the product-related supplier quality within… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, ISO 11135,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Vice President, Business Development Quality will organize and oversee the Quality, Regulatory Affairs and Compliance activities in support of Business ... roles will report into this role directly: Director Business Development Quality, Sr . Manager Business Development Quality, Sr Quality Auditor, other Director… more
- Olympus Corporation of the Americas (Westborough, MA)
- …perspective. Matrixed relationships within Olympus will include colleagues from Quality Assurance, Regulatory Affairs , IP R&D teams, and the Infection Prevention ... Collaborate with the Chief Medical Safety Officer, Chief Medical Officer, and other senior leaders within Medical and Scientific Affairs to share best practices… more
- Takeda Pharmaceuticals (Boston, MA)
- …and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) + In alignment with TAU/MPD Labeling Lead, ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) driving… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... regulators ensuring communicationsadhere the Global Quality System and applicable regulatory requirements. + Responsible for reviewing complaint handling requests… more
- Children's Hospital Boston (Boston, MA)
- …role will serve as the primary point of contact for legal affairs at Franciscan Children's and other affiliated organizations, providing strategic legal guidance ... and risk management to address legal and regulatory issues and optimize operational alignment and compliance with...compliance with the OGC. The position will report to senior leadership at the OGC with a matrixed reporting… more
- AbbVie (Cambridge, MA)
- …of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs . Must possess solid foundation of generally accepted ... assessments of individual partnering opportunities to therapeutic area leadership and senior governance committees as well as contributing to Immunology and BD… more