- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product Labeling for FDA ... more
- Aequor (Irvine, CA)
- …System policies and procedures and applicable external requirements and standards, including FDA , ISO 13485, and other worldwide regulatory agencies as pertaining to ... more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assets within the alliance by effectively liaising, negotiating, and partnering with FDA . This role will create and implement effective regulatory strategies to ... more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to ... more
- Merck & Co. (Rahway, NJ)
- …our company with external organizations through direct communication with the FDA , including telephone calls and e-mail; chair meetings between company and ... more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with Quality, Manufacturing, Regulatory, and subject matter experts to prepare for FDA and other agency auditsEnsure site/system validation program meets FDA , ... more
- Aequor (Atlanta, GA)
- …data appraisals in alignment with EU MDR, MEDDEV 2.7/1 Rev. 4, and FDA guidance. Review and summarize large clinical documents such as literature reports, clinical ... more
- Formation Bio (New York, NY)
- …quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA , EMA), industry standards (eg, cGMP), and company policies. Establish and ... more
- Formation Bio (New York, NY)
- …teams to support drug diligence, development and regulatory interactions, FDA briefing books, and submission-related activities. Represent Biostatistics in key ... more
- Merck & Co. (Rahway, NJ)
- …strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human ... more
- Tris Pharma (Monmouth Junction, NJ)
- …current Good Manufacturing Practices (cGMPs), Food and Drug Administration ( FDA ) standards and batch record specifications.The incumbent uses systems thinking ... more
- Novo Nordisk Inc. (San Diego, CA)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... more
- Genmab (NJ)
- …in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA , EMA, and ICH guidance for drug development pertaining to ... more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …commercial and investigational drug product is constantly assessed to comply with FDA premises and regulation, another applicable GMP guidelines and internal DS ... more
- Novo Nordisk Inc. (Chicago, IL)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... more
- Merck & Co. (Omaha, NE)
- …leading Import Center of Excellence in the EU, and managing interactions with FDA , DEA, USDA, and US customs, as well as compliance (CTPAT) and regulatory ... more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... more
- Merck & Co. (Durham, NC)
- …tools Experience with responding to regulatory questions with multiple agencies (eg FDA , EMA) Experience with face to face presentation of technically complex ... more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preparation for and during internal and external regulatory audits (including FDA , EMEA).Responsible to maintain permanent inspection readiness and actively support ... more
