- Regeneron Pharmaceuticals (Cambridge, MA)
- …team and provide regulatory leadership and oversight to the development of innovative regulatory affairs and CMC regulatory strategies, guidance and ... and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic...for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC )… more
- Ascendis Pharma (Palo Alto, CA)
- …States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area ... as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to...devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in… more
- Amgen (Washington, DC)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What ... you will do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global … more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Bristol Myers Squibb (San Diego, CA)
- …information. This role will work cross-functionally with several departments (Clinical Operations, CMC , Regulatory Affairs , Supply Chain, Drug Safety/PV, ... to be the global leader in radiopharmaceuticals . The Director , Medical Affairs Research Operations, plays an...are aligned to study specific timelines + Work with regulatory affairs to ensure that all investigator-initiated… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) ... and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructivelychallengeteams to reachthebest solutions… more
- Lilly (San Francisco, CA)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs , Global Regulatory Lead (GRL) ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in...across multiple countries + Direct experience in clinical and CMC regulatory sciences + Knowledge of Global… more
- J&J Family of Companies (Raritan, NJ)
- …regulatory strategies are in alignment with product portfolio, regional strategies, CMC - Regulatory Affairs strategy, commercial and market access ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...**We are searching for the best talent for a Director , North America Regulatory Leader (Oncology) to… more
- Bayer (Whippany, NJ)
- …Files, etc.); + Lead and/or participate in key new product development Regulatory Affairs Teams and/or Global Project Teams; effectively collaborate with ... **Email:** hrop_###@bayer.com **Job Segment:** Medical Device, Biomedical Engineering, Compliance, Regulatory Affairs , Product Development, Healthcare, Engineering, Legal,… more
- Amgen (Washington, DC)
- …development through commercial + Collaborate with cross-functional leaders in Quality, Regulatory Affairs , Process Development, Manufacturing, and Supply Chain ... the lives of patients while transforming your career. **Senior Director , Product Quality** **What you will do** Let's do...business imperatives + Provide functional and cross-functional review of regulatory CMC submission content + Serve as… more