- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/ Device , and Global Regulatory Affairs . + Advanced knowledge of ... interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be...Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary… more
- Takeda Pharmaceuticals (Boston, MA)
- …with key functions across Takeda Oncology including Translational Medicine, Clinical Sciences, Global Regulatory Affairs , the Oncology Business Unit ... and clinical data integration. + Understanding of key considerations relevant to global regulatory requirements + Experience developing team culture, resolving… more
- Hologic (Marlborough, MA)
- …Services globally. You will collaborate with key stakeholders, including Regulatory Affairs , Quality Assurance, Supplier Quality Assurance, Engineering ... Solutions Analyst, Global IT Quality Solutions** to join our **Quality, Regulatory , and Product Life Cycle Management Systems Center of Excellence (COE)** . This… more
- Olympus Corporation of the Americas (Westborough, MA)
- …deliverables from assigned projects as required by the SDLC and will support Regulatory Affairs ' efforts in creating submission materials for various ... Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs , etc. + Independent organizational and time management skills… more
- J&J Family of Companies (Danvers, MA)
- …Officer. The MSO will build clear and strong relationships between Medical Affairs , R&D, Quality, Regulatory , Clinical, Epidemiology to allow for proactive ... and safety communications. + Stakeholder Collaboration: Work closely with Medical Affairs , R&D, Quality, Regulatory , and other cross-functional teams to… more
- Bristol Myers Squibb (Devens, MA)
- …in pharmaceutical (medical device , biologics) facilities. + In-depth knowledge of global regulatory requirements (FDA, EMA, PMDA, etc.) and GxP standards. + ... agency inspections (eg, FDA, EMA, PMDA, etc.) across global pharmaceutical, biotech, cell therapy, and medical device...fields, required. + 10+ years of relevant experience in regulatory affairs , compliance, or quality assurance in… more
- J&J Family of Companies (Danvers, MA)
- …on existing and future programs. + Maintain strong partnership with Medical Affairs field team, Global Strategic Marketing, US Commercial Marketing, PPD ... for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Professional Medical Education **Job Category:**… more
- J&J Family of Companies (Raynham, MA)
- …and provides consultative direction as well as technical guidance to R&D, Clinical Affairs , Regulatory Affairs , Product Stewardship, Surgical R&D and ... medical device (MD) products as per internal procedures and global standards and regulations. This person applies technical expertise, ingenuity, business… more
- Edwards Lifesciences (Boston, MA)
- …Familiarity with FDA PMA applications. + Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more