- Fujifilm (Boston, MA)
- …on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma companies. + Provide ... to HLUS and its subsidiary companies on substantive legal topics, including FDA marketing and advertising regulations and other regulations specific to Life… more
- Kelly Services (Marlborough, MA)
- …suppliers. The ideal candidate will also bring expertise in validation processes and FDA Design Controls and serve as a technical mentor within the organization. ... components and systems. + Develop and maintain documentation in alignment with FDA Design Controls, including design inputs, outputs, and traceability. + Create and… more
- Sanofi Group (Cambridge, MA)
- …counsel concerning a broad range of legal issues, including, interpretation of FDA and other regulations, including the False Claims Act, Anti-Kickback Statute and ... legal issues (focusing on antitrust matters, potential litigations and promotional matters, FDA /regulatory issues and fraud and abuse) as well as proposed solutions… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports ... point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as...of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. +… more
- System One (Devens, MA)
- …executed batch records; support lot disposition + Participate in internal audits, FDA inspections, and client audits + Support quality systems, document control, and ... 5-7 years, or MS with 3-5 years in an FDA -regulated industry + Minimum 7+ years in GMP QA...life sciences + Strong background in CAPAs, deviation investigations, FDA audits, and document control + Experience with APIs,… more
- Philips (Cambridge, MA)
- …Build proactive, strategic relationships with external stakeholders (notified Bodies, US FDA , Competent Authorities, etc.) to ensure that requirements are known ... time. + Your skills include extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical Documentations/Design… more
- Beth Israel Lahey Health (Boston, MA)
- …Assist investigators and study teams in preparing and submitting IND applications to the FDA . + Preparation and submission of annual reports to the FDA ; ... years related work experience required. + Must demonstrate good understanding of FDA , cooperative group, NCI and OHRP regulatory guidelines. + Must maintain… more
- North Coast Seafoods (Boston, MA)
- …work. + Safety & Compliance: Enforce safety regulations and compliance with OSHA, FDA , USDA, and GMP standards in a seafood manufacturing environment. + Inventory ... of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer… more
- Sumitomo Pharma (Boston, MA)
- …+ Distributing, and archiving all incoming and outgoing communications with FDA and international counterpart agencies. + Understands evolving Health Authority (HA) ... the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment Registrations, Drug Product Listings). + Manages… more
- Abbott (Burlington, MA)
- …report needs to be filed with various global regulatory agencies (eg, FDA , European Competent Authorities) and sends reports within required timeframes, consulting ... regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more