- Formation Bio (New York, NY)
- …mission to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical… more
- Larimar Therapeutics (Philadelphia, PA)
- …will be a key member of project teams and the role reports to the Regulatory Affairs Senior Director . Job Duties/Responsibilities: Larimar Team ... welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide...the development programs of Larimar. Works closely with RA Sr . Director and serve as backup to… more
- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for...of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain up-to-date… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be responsible ... dashboards to communicate key findings and recommendations to internal stakeholders, including senior leadership and medical affairs teams. Ensure utilization of… more
- Merck & Co. (Upper Gwynedd, PA)
- …analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior Director may be responsible for: -Analyzing and summarizing ... radically changes the way we approach serious diseases. --The Senior Director will report to an Associate...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as part of the Novo Nordisk portfolio. Relationships This position reports directly to the Senior Director , Medical Affairs and will assist the Executive ... the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director...Plan (EGP), in collaboration with Sr . Medical Director Serve as NNI Medical Affairs representative… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director ( Sr . Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving ... execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre-clinical and… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Senior Director , Medical Services will provide strategic leadership to Insmed's independent ... strategies to fill core educational and research gaps. The Senior Director , Medical Services will drive operational...relevant guidelines including, but not limited to medical and regulatory affairs , drug development, FDA and … more
- Insmed Incorporated (NJ)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our TPIP program in Pulmonary ... alignment of US HCP activities with field execution.Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial Operations… more
