- Tecomet (Woburn, MA)
- …as Official FDA Correspondent. + Serve as person responsible for regulatory compliance (PRRC). + Assist and complete site FDA /ISO/AS/EAR Registrations + ... Host FDA and government and notified regulatory agencies audits. + Review and interpret regulatory...ACTION EMPLOYER / PROTECTED / VETERANS / DISABILITIES / DRUG FREE WORKPLACE** **TRAVEL REQUIREMENTS:** X **YES** **NO** **INTENT… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …reports, to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, ... documents for SRC and IRB review and approval + Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious… more
- Takeda Pharmaceuticals (Boston, MA)
- … submissions. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. ... bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global … more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …Director might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements (affairs and CMC) for investigational and ... through lifecycle management. + Responsible for the strategic company guidance on FDA and global regulatory CMC requirements for investigational and commercial… more
- BeOne Medicines (Cambridge, MA)
- …and negotiates with FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals ... including responsibility clinical protocol/safety amendments, supplements, and annual reports; + Drug development process; + FDA regulations; + ICH guidelines;… more
- Takeda Pharmaceuticals (Boston, MA)
- … submissions. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
- Sumitomo Pharma (Boston, MA)
- …Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment Registrations, Drug Product Listings). + ... and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and… more
- Fresenius Medical Center (Waltham, MA)
- …commercialization of pharmaceutical products. + Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory ... timely approval and market access across key regions (eg, FDA , EMA, Health Canada, etc.). Including global chemistry, manufacturing,..., EMA, HC, etc.). + Strong expertise in navigating regulatory pathways for drug strategy, from preclinical… more
- Sumitomo Pharma (Boston, MA)
- …a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, guidance ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more
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