- Tecomet (Woburn, MA)
- …Affairs will play a critical role in transforming and optimizing the Company's global quality and regulatory strategy, delivering operational excellence, and ... EU, Asia, Australia markets. + Provide strategic leadership and oversight to the Global Quality Assurance and Regulatory Affairs function, setting clear… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring the ... This role focuses on defining activities, processes, and standards to meet quality requirements relevant to deviation management and serious breach. This position… more
- Symmons Industries (Braintree, MA)
- …to our customers, product engineering and operations within our manufacturing facility. The Director of Quality will ensure that all products meet or exceed ... from you! TheDirector of Qualitywill be r esponsible for executing Symmons' Quality strategy ensuring alignment with business goals and objectives, while providing… more
- Sanofi Group (Cambridge, MA)
- …diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within ... **Job Title:** GRA Device Lead ( Director ) **Location** : Morristown, NJ, Cambridge, MA, Framingham,...Global Research and Development. Sanofi's global regulatory affairs (GRA) function is comprised… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director /Principal Medical Writer **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ready to shape the future of ... who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an… more
- Bayer (Cambridge, MA)
- …Accessible, Interoperable, Reusable), data standards (eg IDMP), to enhance the quality , efficiency and effectiveness of regulatory operations and pharmaceutical ... to make a real difference, there's only one choice.** ** Director R&D Reg Data Mgmt Expert DSAI** **YOUR TASKS...regulatory exchanges and data therein; + Understanding of global pharmaceutical regulatory requirements, data standards (eg,… more
- Hologic (Marlborough, MA)
- …ISO standards (eg, ISO 13485:2016, ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality Systems and GMP compliance in ... a pivotal role in ensuring the effectiveness of our global Quality Systems. In this critical leadership...ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you thrive in… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Ensure clinical operations deliverables and work product are compliant with global regulatory and compliance requirements for clinical research, including but ... your future at Takeda. Join us as the Executive Director of Clinical Operations reporting to the Head of...complex global studies. + Expert knowledge of global regulatory and compliance requirements for clinical… more
- Pfizer (Cambridge, MA)
- …data management, result interpretation, and providing statistical support and leadership in global regulatory submission activities, as well as implementing new ... **JOB SUMMARY** The Director will plan, direct, and coordinate specialized and complex global development projects led by the Rheumatology group within the… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical ... and empower you to shine? Join us as a Director , Quantitative Clinical Pharmacology Lead in our Cambridge, MA...Experience in representing the QCP function in interactions with global or regional regulatory agencies at significant… more