- 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)
- …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
- 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
- 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
- Aequor (Chattanooga, TN)
- …Operating Procedures (SOP's), Good Manufacturing Practices (GMP) Compliance, and Food and Drug Administration ( FDA ) regulatory standards. Maintain compliance ... Peer Relationships, Directing Others, and Comfort Around Higher Management o Experience in Food or Pharma manufacturing following FDA regulations is preferred. more
- Merck & Co. (Rahway, NJ)
- …product portfolio.-3. Collaborate with cross-functional partners, including R&D, Quality, Regulatory , Manufacturing, Technical Product Leaders, and Value Chain to ... and improve product stewardship practices, while ensuring compliance with regulatory requirements.6. Foster a culture of excellence, mentorship, and professional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed for FDA - approved labeling including updates to Reference Listed Drug , USP updates and updates for new Regulatory requirementsTrack global affiliate ... for FDA submission, create and modify Structured Product Labeling for FDA submission, complete electronic drug listing, track and archive affiliate labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracks regulatory trends, legislative changes, and guidelines issued by global regulatory agencies ( FDA , EMA, MHRA, etc.) related to CSPV. Participates in ... both investigational and marketed products required- Knowledge of Adverse Event and drug coding conventions (MedDRA, WHO-DD)- Knowledge of FDA and global… more
- Merck & Co. (Rahway, NJ)
- …years of leadership experience with deep working knowledge of device, biologic/ drug product, and process development including regulatory submission and ... & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and… 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)
- …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
- 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
- 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. The ... methods for raw material, in-process, and finished product per USP and FDA guidanceProvides work assignments with communication of the expected timelines to… 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 ... thermal energy principals, mechanical maintenance techniques, and electromechanical theoryEnsures regulatory and job training remains current by promptly completing… 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 training.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference ... process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the regulatory requirements of the US Food and Drug Administration.Experience RequirementsKnowledge and experience with FDA regulations.Self-motivated with ... well as reviewing and approving data associated with Raw Material, Finished Drug Products, Stability and Microbiology testing. Data Review may include release, raw… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job ... Responsibilities:Draft and review technical documents supporting raw material and/or drug product release and stability with some supervisionPerform calibrations and… more
- Tris Pharma (Monmouth Junction, NJ)
- …and industry standards related to Medical Affairs role including Food and Drug Administration ( FDA ), Office of Inspector General (OIG), Pharmaceutical ... processes and compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to medical inquires, disseminate scientific… more
