- 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 ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...is also responsible for maintaining product and establishment registrations ( drug /establishment listings) and submission to FDA databases.… more
- Merck & Co. (North Wales, PA)
- …developmental compounds or marketed products throughout the entire life cycle of the drug .Provides leadership as head of the Global Regulatory Team, which ... Job DescriptionThe Regulatory Affairs Headquarters Principal Scientist is responsible for...FDA ; prepares our company teams for meetings with FDA at all phases of drug development.Leads… more
- 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 ... US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with … more
- Merck & Co. (Rahway, NJ)
- …between company and FDA ; prepare our company's teams for meetings with FDA at any phase of drug development. Lead cross-functional efforts to prepare ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our… more
- Merck & Co. (Rahway, NJ)
- …between company and FDA ; prepare our company teams for meetings with FDA at any phase of drug developmentLead cross-functional efforts to prepare for ... BS or MS with a minimum of 10 years of relevant drug development experience with majority in regulatory orM.D. or PhD/PharmD with a minimum of 7 years relevant … more
- 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 ... strategy for assigned project(s). Strategize and plan for FDA meetings.Serve as the primary contact with FDA...More Years in regulatory affairsExperience in providing regulatory strategic input into the drug development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …teams for and leading meetings with regulatory agencies, including the FDA Experience with rare disease drug development, innovative trial design and/or ... preferred Minimum of 8 years total pharmaceutical/related industry experience in drug development required Demonstrated knowledge of global regulatory … 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 ... reports directly to the Vice President, CMR Strategic Operations. External relationships include regulatory authorities: FDA and Health Canada AE and MDR and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for performing a wide range of activities to support the release of drug products for human use. This position is responsible for quality and maintaining ... procedures, and all applicable regulations.Key Responsibilities Manage the team responsible for drug product batch record review and drug product release… 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 ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...compliance is met with all internal and external (eg FDA ) drug and device safety reporting regulations.… more
- Tris Pharma (Monmouth Junction, NJ)
- … regulatory packages per International Council for Harmonization (ICH)/Food and Drug Administration ( FDA ) guidance and provides technical guidance within and ... outside R&D for regulatory and quality matters.The Associate Director/Director, AR&D serves as...for complex technologies In depth knowledge of Food and Drug Administration ( FDA ), cGMPs, Drug … more
- Merck & Co. (Durham, NC)
- …Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, ... in science or related fieldBioworks Certificate (working in an FDA or similar regulated industry)Applicable mechanical and project management experienceExperience… more
- Merck & Co. (Rahway, NJ)
- …include development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, ... non-sterile and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our partners… more
- Merck & Co. (Rahway, NJ)
- …DescriptionAs part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… 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 a strong candidate… more
- Merck & Co. (Rahway, NJ)
- …to identify, mitigate, and clearly articulate program risks.Demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC, and ... new formulations and development of robust and scalable processes for parenteral drug products within the small molecule and synthetic modality pipeline.The Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data ... collectionSupports Regulatory affairs in providing content and providing review of...providing review of documents supporting CDx submissions to the FDA and other health authorities globallyFor late-stage programs, executes… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA , EMEA).Maintains various databases of production ... process changes/improvement.Partner with all stakeholders to implement process improvements.Assure regulatory compliance and technical feasibility of proposed changes.Serve as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …local, state and federal regulations including and equivalent to Federal Drug Administration ( FDA ), Environmental Protection Agency (EPA), Occupational Safety ... of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA's.Ensures regulatory and job training remains current by promptly completing required… more
