- Cardinal Health (Boston, MA)
- …collaborate with subject matter experts from other departments, especially the Legal, Regulatory Counsel and Compliance teams + Demonstrate knowledge of general ... to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company… more
- CGI Technologies and Solutions, Inc. (Burlington, MA)
- …be responsible for managing the validation activities, quality assurance processes, and regulatory compliance for pharmaceutical projects. This role requires ... and QA activities for the organization's Quality Management Systems (QMS), ensuring compliance with pharmaceutical regulatory requirements (FDA, EMA, etc.).… more
- Takeda Pharmaceuticals (Boston, MA)
- …and submission support perspective. + Provide strategic leadership for end-to-end regulatory compliance and process efficiencies across the PDT organization. ... and previous experience to develop innovative and flexible approaches to ensure regulatory compliance . **More about us:** At Takeda, we are transforming… more
- Fresenius Medical Center (Waltham, MA)
- …the global development and commercialization of pharmaceutical products. + Ensure compliance with local and global regulatory standards, including FDA, EMA, ... AND SCOPE:** Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays… more
- Chiesi (Boston, MA)
- …communications including social media, press releases, and talking points + Ensures regulatory compliance while effectively managing business risks + Understands ... regulatory guidance documents and initiating changes in systems to ensure regulatory compliance . Knowledge of Common Technical Document and global guidelines… more
- Sumitomo Pharma (Boston, MA)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral ... Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write… more
- Takeda Pharmaceuticals (Boston, MA)
- …BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. + 8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product ... development and registration strategies. You will be RA CMC member on Regulatory , Pharmaceutical Development, and Production project teams throughout clinical… more
- Merck (Boston, MA)
- …Biological Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, ... Pharmaceutical Regulatory Affairs, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance , Regulatory Reviews, … more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance . + Ensures global regulatory strategies defined within ... to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. + Is a leader both in… more