- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... provide US regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... directly to the Vice President, CMR Strategic Operations. External relationships include regulatory authorities: FDA and MDR and relevant vendors. Internal… more
- Formation Bio (New York, NY)
- …Development teams to support drug diligence, development and regulatory interactions, FDA briefing books, and submission-related activities. Represent ... and late-stage development. Strong understanding of regulatory guidelines for drug development, including FDA and EMA requirements for statistical practice,… more
- Formation Bio (New York, NY)
- …maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA , EMA), industry standards (eg, cGMP), and ... and educate stakeholders at all levels of the organization. Experience leading regulatory inspections (eg, FDA inspections, MHRA inspections, EMA inspections,… more
- Formation Bio (New York, NY)
- …and/or pharmacovigilance documents are developed in a format compliant with the governing regulatory agency (EMA, FDA , and ICH guidelines) and with electronic ... PhD) is preferred. 7+ years of experience in the development of clinical and regulatory documents to support drug development programs. Experience as lead writer… more
- AUROBINDO (Durham, NC)
- …the accuracy of analytical measurements and compliance with cGMP, US FDA , and other regulatory and corporate requirements.Conducting troubleshooting and ... and validation, with prior supervisory roles being advantageous.Familiarity with pharmaceutical regulatory standards, including USP/ICH/ FDA 21 CFR 210/211, CFR… more
- Formation Bio (New York, NY)
- …that all clinical trials are conducted in accordance with ICH-GCP guidelines, FDA regulations, and other applicable regulatory requirements. Ensure that clinical ... AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug ...executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and inspection preparedness for the respective MA inspections in alignment with regulatory and company strategy. Act as management representative for all key health ... authority inspections (US FDA , EU EMA, MHRA etc.,). Develop and maintain an...Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory AffairsLeadership/ team management:Create a high performing team environment… more
- Merck & Co. (Rahway, NJ)
- …Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Formation Bio (New York, NY)
- …and educate stakeholders at all levels of the organization. Experience leading regulatory inspections (eg, FDA inspections, MHRA inspections, EMA inspections, ... is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more… more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Merck & Co. (Rahway, NJ)
- … drug product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA , ICH, ... In summary, our team enables the translation of preclinical candidates into non-oral drug products.We are seeking a highly motivated candidate for the position of… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive ... is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more… more
- Genmab (NJ)
- …in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA , EMA, and ICH guidance for drug development pertaining ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation… more
- Merck & Co. (Rahway, NJ)
- …effective technical and communication skills, and a strong understanding of the drug development and regulatory landscape to influence it positively.Nature and ... teams responsible for developing characterization methods to evaluate and release clinical drug substances and products and their stability tests for our research… more
- Tris Pharma (Monmouth Junction, NJ)
- …Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration ( FDA ) standards and batch record specifications.The ... efforts, quality operations, etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA , as well as all applicable company compliance guidelines, standards… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA , GLP, QSR, cGMP, USP, and CDR ... support.Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and combination drug … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions. Contributes ... and manages multiple Companion Diagnostics Partnerships to develop, implement and gain regulatory approvals for CDx assays. May function as the main point of… more
- Tris Pharma (Monmouth Junction, NJ)
- …to strategy discussions in cross functional settingsExperience interacting with the FDA and other regulatory organizationsHands-on experience with statistical ... accuracy and integrity, contributing to research protocol development and supporting regulatory submissions. Provides expert statistical input in design and analysis… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- 7 or more years training and compliance background and strong knowledge of FDA and EU regulatory requirements, industry audit processes, and Data Management ... and other vendors to ensure high quality of deliverables to support drug development processes and global submissions. This position provides leadership within Data… more
