- Merck & Co. (Rahway, NJ)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Merck & Co. (Rahway, NJ)
- …subject matter expert in flow cytometry, working with project teams, biomarker leaders, clinical operations, regulatory affairs , and physicians to implement ... complex datasets. Regulatory Knowledge: Understanding of regulatory guidelines ( FDA , EMA) pertaining to biomarker development and clinical trial… more
- Formation Bio (New York, NY)
- …needed. Collaborate with cross-functional teams (eg, Engineering, Tech, R&D, Manufacturing, Regulatory Affairs ) to ensure alignment on quality objectives, ... maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA , EMA), industry standards (eg, cGMP), and… more
- Formation Bio (New York, NY)
- …and preventive actions (CAPA as needed. Collaborate with cross-functional teams (eg, CMC, Regulatory Affairs , Clinical Operations) to ensure alignment on ... and perform batch record reviews to ensure accuracy, completeness, and compliance with regulatory requirements. Manage QA release of clinical trial materials to… more
- Merck (Rahway, NJ)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide ...if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure ... advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess regulatory... FDA , EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures and oversee… more
- System One (Florham Park, NJ)
- Job Title: Director, US Regulatory Affairs Location: Florham Park, NJ (50% hybrid) Type: contract Overview: Support the Global Therapeutic Area Lead (GTAL), ... Regulatory Affairs (Senior Director) in developing and...a cross-functional team environment. + Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations… more
- L'Oreal USA (Clark, NJ)
- …from all global R&I hubs in Advanced Research and other partners across clinical functions, regulatory , development labs, brand partners to ensure scientific ... programs to internal and external stakeholders on relevant projects and innovations. + Clinical Trial Support: Provide medical affairs support for clinical … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to requests for information, consistent with promotional compliance, PhRMA guidelines, and FDA regulatory requirements + Implements defined goals and objectives ... reporting to a Field Director. The MS will disseminate clinical information about Gilead's innovative hematology and oncology products...aligned with the Medical Affairs Plan of Action and other strategic initiatives +… more
- Veterans Affairs, Veterans Health Administration (New York, NY)
- Summary The Biomedical Equipment Support Specialist provides clinical and administrative support to staff, patients, and administrators for all matters of concern ... throughout VA. Responsibilities The Biomedical Equipment Support Specialist provides clinical and administrative support to staff, patients, and administrators for… more
- Sanofi Group (Bridgewater, NJ)
- …of US Regulatory strategies (eg, submissions, product defense, labeling development, FDA enforcement, clinical trial support, FDA contacts). + Provide ... you will be the primary therapeutic area liaison with FDA 's Office of Prescription Drug Promotion (OPDP) for drugs,...started? **Main Responsibilities** + In conjunction with the Global Regulatory Affairs Head of Global Advertising &… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Senior Regulatory Affairs Manager will provide strategic leadership to support new product development (NPD) programs for our ... primary point of contact between the business units and regulatory affairs team. + Develop robust strategy...process. + Actively manage projects through all phases of clinical trial research and commercialization, ensuring timely completion of… more
- Bausch Health (Newark, NJ)
- …Management, CMC, Analytical Sciences, Nonclinical, Clinical Operations, Clinical /Medical Affairs , Biostatistics, and Regulatory Affairs . + Lead the ... Responsible for the technical content and timely completion of clinical pharmacology deliverables as well as regulatory ...dermatology drugs is preferred. + Track record of successful regulatory agency (US FDA ) submissions and interactions… more
- Danaher Corporation (New York, NY)
- …within medical device (IVD preferred), biotech, or pharmaceutical + Working knowledge of FDA regulatory requirements related to clinical research + Strong ... and mentorship to Clinical Operations staff.This position is part of the Clinical Affairs department and will be Remote.In this role, you will have… more
- Merck (Rahway, NJ)
- …subject matter expert in flow cytometry, working with project teams, biomarker leaders, clinical operations, regulatory affairs , and physicians to implement ... datasets. + ** Regulatory Knowledge:** Understanding of regulatory guidelines ( FDA , EMA) pertaining to biomarker development and clinical trial processes.… more
- Bristol Myers Squibb (Summit, NJ)
- …with site external functions to drive resolution (eg Supplier Quality, Medical Affairs , Patient Safety, Regulatory Affairs , Global Quality Systems, ... remediation, QMS implementation, etc.). + Prior experience interacting with FDA or other regulatory agencies. + Ability...T or Biologics is preferred. + Professional certification in Regulatory Affairs or quality certifications is desired.… more
- Sanofi Group (Morristown, NJ)
- …clinical data. + Interact with relevant teams Innovation, Regulatory , Pharmacovigilance, Evidence generation (eg biostatisticians, Medical Writers, Monitoring ... team, eDS, etc.), Scientific Affairs and Growth (eg Marketing representatives when relevant). Common...Technical Document (CTD) + Coordinate the preparation of the clinical part of the CTD for FDA … more
