- Cardinal Health (Boston, MA)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions ... knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct...Support research to maintain a pulse on product, supplier, regulatory , and market dynamics; understand how industry trends may… more
- Dana-Farber Cancer Institute (Boston, 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,… more
- Sanofi Group (Cambridge, MA)
- …and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and ... **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge,...FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications. + Primary Liaison… 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
- Takeda Pharmaceuticals (Boston, MA)
- …regulatory submissions. + Expert knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… 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
- Rhythm Pharmaceuticals (Boston, MA)
- …experience in Regulatory Affairs Operations + Knowledge and understanding of the drug development process + Strong knowledge of FDA and Global EU/UK ... to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory … more
- Chiesi (Boston, MA)
- …and rewarding work. Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials for all Chiesi ... to existing labeling, and submission of labeling information to regulatory authorities in the United States and Canada. Main...and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing… more