- GRAIL (Boston, MA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- CSL Behring (Waltham, MA)
- …CSL's reputation and policy position. **Reporting Relationships:** **Reports to:** Associate Director , Corporate & External Affairs , R&D Portfolio **Main ... **Position Title:** Senior Manager, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Senior Manager,...Responsibilities and Accountabilities:** + Support the Associate Director in serving as a business partner and advisor… more
- Unknown (Boston, MA)
- …CMC development programs. The ideal candidate will have a strong background in Regulatory Affairs CMC, with experience leading regulatory strategies and ... expertise and guidance to the client contact for CMC development teams. The Director will also lead regulatory intelligence activities, monitoring changes in… more
- Merck & Co. (MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Pfizer (Cambridge, MA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. Foster a transparent environment that builds strong partnerships… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Strong cross-functional collaboration experience, including working with Legal, Compliance, Regulatory , Medical Affairs , and Clinical Operations. + Familiarity ... in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + Other duties as… more
- Cipla (Fall River, MA)
- …committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs , regulatory affairs , quality assurance, procurement etc. ... management. In collaboration with Cipla commercial, supply chain management and regulatory affairs , responsible for launch planning, launch risk mitigation… 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) ... supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the governance of the… more
- Commonwealth Care Alliance (Boston, MA)
- …(eg, Claims, Credentialing, Clinical Care Management, Member Services, Provider Services, Regulatory Affairs , Marketing) to resolve provider issues and reduce ... with other CCA departments, including Clinical Management, Member Services, Claims, Regulatory Affairs , Outreach and Marketing, to resolve provider issues.… more
