- Sanofi Group (Morristown, NJ)
- …this innovative therapeutic platform. The position is within the mRNA Therapeutic Area, reporting to Global Regulatory Lead. As a key member of the Global ... **Main Responsibilities** + The Regulatory Strategist (RS) enables the Global Regulatory Lead (GRL) providing quality regulatory input and position to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner ... Team with considerable responsibilities to develop, continuously improve and innovate global regulatory and labeling policies, practices, processes, tools, team,… more
- Gilead Sciences, Inc. (Foster City, CA)
- … regulatory lead you will also be responsible for ensuring that global regulatory strategy is integrated into Pharmaceutical Development & Manufacturing (PDM) ... molecules in the Biologics portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of global ... activities for assigned Clinical Trial Application projects in alignment with the Global Regulatory Lead (GRL). + As an integral member of Otsuka's Regulatory… more
- AbbVie (Mettawa, IL)
- …the highest quality and regulatory standards. Designs and delivers optimized global regulatory strategies, plans and dossiers that align with AbbVie's ... strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan. Leads the international… more
- AbbVie (Pleasanton, CA)
- …communicate requirements. * Ensures planned device development activities comply with US and global regulatory guidelines, and, in cases where they do not, ... Company, as required * Establishes relationships with US colleagues as well as global regulatory team to ensure local RA activities are in line with global… more
- Kemin Industries (Des Moines, IA)
- …for Kemin products deemed necessary to achieve business outcomes such as global regulatory approvals and clearance for Kemin Health ingredients, labels, ... will provide guidance throughout all stages of innovation and commercialization, support global customers on regulatory and quality-related matters, and ensure… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Global Regulatory Policy and Intelligence Manager** **What you will do** The ... regulatory requirements, as needed. + Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory … more
- Bausch Health (Bothell, WA)
- …progress and impact. Responsibilities: + Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of ... regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as US FDA product clearance, Health Canada registration, CE… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …tactical plans for submissions + Prepares, or directs the preparation of global regulatory submissions + Support the monitoring, interpreting, and implementing ... + RAPS RAC certification preferred + Six Sigma desired + Knowledge of global Regulatory Affairs requirements, regulations and standards + Strong critical… more