- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III...and PMA reporting + Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performing… more
- Boehringer Ingelheim (Ridgefield, CT)
- …preferred + Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification preferred ** Associate Director Experience Requirements:** ... the global and US cross-functional teams. They will also provide US strategic regulatory guidance to facilitate efficient and compliant drug development and… more
- Kelly Services (Thousand Oaks, CA)
- Research/ Sr Research Associate - CNS Drug Delivery **Job Summary:** Our client, an innovative neuroscience company at the forefront of biotechnology, is focused ... of their expanding team, they are seeking a **Research Associate ** or **Senior Research Associate ** to support...to support bioanalytical and in vivo studies in CNS drug delivery. This role will be pivotal in advancing… more
- United Therapeutics (Research Triangle Park, NC)
- …of preclinical studies to ensure the successful submission and approval of a drug product by regulatory agencies. This role will provide scientific insight ... pharmaceutical company experience in clinical development with a PhD/PharmD + For Clinical Drug Development Associate Director level: + 10+ years of product… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Position Overview** Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of ... safe and efficacious drug products, through effective quality oversight of North, Central...launching new products, packages, processes, and CM's. The Principal Associate QA may also be responsible for final disposition… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Job Summary** **** The Associate Director, MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- Lilly (Indianapolis, IN)
- …and updating approved global product registrations for drug substances and drug products. + Utilizes specialized scientific and regulatory expertise to ... + Demonstrated scientific knowledge in drug development including API, or Drug Product or Analytical + Demonstrated CMC regulatory experience **Additional… more
- Boehringer Ingelheim (Ridgefield, CT)
- …We realize that our strength and competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the ... and post marketing reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- Merck (Rahway, NJ)
- …+ Review process change requests and deviation reports while ensuring regulatory compliance. **Education and Minimum Requirements:** + Bachelor's degree in ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause Analysis (RCA), Stakeholder Engagement, Stakeholder… more
- Cambrex High Point (High Point, NC)
- …a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire ... career where You Matter by applying today! Job Overview The Senior Scientist, Regulatory Compliance will provide oversight of regulatory compliance activities to… more