- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and approvalsExtensive experience developing companion diagnostics and devices.Experience of drug development and drug regulatory procedures.Understanding ... of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device...deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.Experience with developing… more
- Merck & Co. (Rahway, NJ)
- …model-informed regulatory framework to impact strategies and decisions of drug discovery and development teams. Collaborate with other functional areas, as well ... of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. Educational background in… more
- Merck & Co. (Rahway, NJ)
- …Skills: Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain ... (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply… more
- Merck & Co. (Rahway, NJ)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... key stakeholdersPosition Specific Required Skills and Experience: US and/or worldwide drug or vaccine regulatory application submission experience including the… more
- Merck & Co. (North Wales, PA)
- …that include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- …processes (SOPs) and software development life-cycle (SDLC) US and/or worldwide drug or vaccine regulatory application submission experience including the ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …strategy.Deep and broad working knowledge of pharmaceutical vaccine/biologic/small molecule drug product and process development including regulatory submission ... & Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug / vaccine - device enabled combination products to achieve safe and… more
- Merck & Co. (San Francisco, CA)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... Pharmacokinetics, Pharmacology, Pharmacometrics, PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills: Drug Discovery Process, Global Regulatory , Machine Learning,… more
- Eli Lilly and Company (Indianapolis, IN)
- …has an expanding and diverse portfolio of ADCs that require thorough drug -linker process development and regulatory submission strategies, often with compressed ... accelerate the development of lifesaving new medicines for our patients. Our antibody- drug conjugate (ADC) team seeks to perform innovative and cutting-edge research… more
- Scientific Protein Laboratories (Waunakee, WI)
- … Drug Master Files (DMF) for US FDA. Keeps with current EC drug substance or Active Pharmaceutical Ingredient (API) regulatory requirements. Keeps current on ... Ingredients (APIs). SPL has an exciting opportunity to join the team as a Regulatory Affairs Specialist. This position is responsible for supporting day to day … more
- Merck & Co. (Boston, MA)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... with ability to understand how MIDD can drive portfolio and regulatory decisionsDeep knowledge of drug development, pharmacokinetics and pharmacology… more
- Merck & Co. (South San Francisco, CA)
- …for planning and management of an important inflection point in the drug development process, working closely with scientific, regulatory , statistical, and ... clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and… more
- Stony Brook Medicine (Stony Brook, NY)
- …a minimum of three (3) professional references. Successfully complete a 4-panel drug screen* Meet Regulatory Requirements for pre-employment screenings. Provide ... The Investigator Initiated Trial Specialist provides operational support and regulatory management for investigator-initiated clinical research at Stony Brook Cancer… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... under development and post approval research, including the development of regulatory strategies to ensure effective achievement of regulatory /business… more
- Vensure Employer Services (Dallas, TX)
- …and follow-up per study timelines. Assist with specimen handling, study drug accountability, and regulatory documentation. Administrative Duties Schedule patient ... and study protocols. Prepare for sponsor site visits, audits, and regulatory inspections as needed Knowledge, Skills, and Abilities Excellent communication and… more
- Abbott (Santa Clara, CA)
- …products for treatment of vascular disease. Our extensive portfolio includes drug -eluting stents, bare metal stents, guide wires, balloon dilatation catheters, ... catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of our… more
- Experis (St. Paul, MN)
- …Opportunity to participate in a global healthcare spin-off. Be a key contributor to regulatory affairs for medical devices and drug products. Work in a ... leader in medical device manufacturing , is seeking a Regulatory Affairs Specialist to join their team, fully remote...waiting period consultants are eligible for: Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account… more
- Goldman Sachs, Inc. (San Francisco, CA)
- …evaluating preclinical and clinical data sets. High degree of familiarity with drug development and regulatory processes including associated risks. Ability to ... role leading all areas of due diligence including scientific, clinical, regulatory , business, financial, operational, legal and IP matters. Manage key aspects… more
- Tyson Foods, Inc. (Springdale, AR)
- Job Details: Job Purpose/Summary: The Director of Regulatory Compliance is responsible for ensuring that the organization adheres to all applicable laws, ... and overseeing comprehensive compliance programs to mitigate risks and ensure regulatory adherence across the organization. The Director of Regulatory … more
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