- 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
- Dana-Farber Cancer Institute (Boston, MA)
- …applications to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA). + Manage the ... deviation, violation, exception, or other event reporting. Ensure various regulatory reporting required are met, Study Sponsor, FDA... regulatory reporting required are met, Study Sponsor, FDA , IRB etc. + Serve as facilitator for study… more