- 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. (Rahway, NJ)
- …US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the operating ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory … more
- Eisai, Inc (Nutley, NJ)
- …supplementary applications in essential. Demonstrated track record of interfacing effectively with FDA , EMA and other global regulatory agencies. Experience in ... your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory … more
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process… 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 ... for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies ( FDA , EMA, PMDA),Guiding project teams preparing submission… more
- Merck & Co. (Rahway, NJ)
- …ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated working knowledge of FDA , ICH, and other ... team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including… more
- Macpower Digital Assets Edge (Los Angeles, CA)
- …and consumer communications. Oversee North American artwork compliance. Manage US regulatory submissions, including FDA drug listings, establishment ... solutions tailored to evolving consumer needs. About the Role: As the Senior Regulatory Affairs Manager , you will ensure regulatory compliance for cosmetic,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global ... controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Merck & Co. (Durham, NC)
- …certification Experience with process risk assessment tools Experience with responding to regulatory questions with multiple agencies (eg FDA , EMA) Experience ... activities for pipeline vaccine programs.- This is position will support vaccine drug substance site readiness and technology transfer focusing on either upstream,… 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
- 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
- Formation Bio (New York, NY)
- … Regulatory Compliance & Submissions Ensure all CMC activities comply with global regulatory expectations (eg, FDA , EMA, ICH); author and review regulatory ... AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug ...commercialization. You will oversee internal and external teams, ensure regulatory compliance, and play a key role in scaling… more
- Insmed Incorporated (San Diego, CA)
- …troubleshooting technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA , and cGMP, evaluating ... Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing analytical methods… more
- Tris Pharma (Monmouth Junction, NJ)
- …throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration ( FDA ), Drug Enforcement Administration (DEA), and ... and minimize obsolescence; Ensures compliance with safety, quality, and regulatory standards in warehouse operationsManages, coaches and mentors direct… more
- Tris Pharma (Monmouth Junction, NJ)
- …Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration ( FDA ) standards. She/he also provides and monitors the ... is cleaned to meet production schedule and in accordance to strict SOP, FDA and cGMP standardsSupports and assists with daily cleaning functions, as needed (vaults,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of ... PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for...management experience in PV preferredMinimum of 5 years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products;… more
- Eisai, Inc (Nutley, NJ)
- …of Clinical Operations and Data Management preferred. Significant experience working with FDA or EMEA regulatory agencies handling responses to inquiries and ... opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase...program level oversight of Clinical development plans (CDP) and drug development Plans (DDP) for marketed products as well… 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)
- …efficient utilization of the warehouse space. This individual will assist in regulatory inspections, perform safety and quality audits, and answer relevant questions ... the optimization and efficient utilization of the warehouse space.Assist in regulatory inspections, perform safety and quality audits, and answer relevant questions… more
