- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and approvalsExtensive experience developing companion diagnostics and devices.Experience of drug development and drug regulatory procedures.Understanding ... interactions (for both sponsor and partner side) CDx RA Policy and Intelligence : Keep abreast of the changing...of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device… 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
- Genmab (NJ)
- …portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within ... work instructions, templates, and associated documentsThis position may also support regulatory policy and/or intelligence deliverables:Monitor the regulatory… more
- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Genmab (NJ)
- … drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various ... talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role modelEnsures consistency of statistical methods and… more
- Genmab (NJ)
- …you join us!The RoleAre you ready to make a meaningful impact in oncology drug development and be part of a dynamic, collaborative team that values innovation, ... Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a team that plays a critical role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project portfolio and prioritize and drive projects from inception through regulatory approval to global implementation.Requirements BS required, Ph.D. preferred in ... network and drive change management process from inception through regulatory approval to global site implementation.Candidate must have extensive experience… more
- Eisai, Inc (Nutley, NJ)
- …will be working with external key opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase II and Phase III studies, and ... critical milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.Direct program level oversight of Clinical development plans (CDP) and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …thermal energy principals, mechanical maintenance techniques, and electromechanical theoryEnsures regulatory and job training remains current by promptly completing ... local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaborating with key stakeholders and functionsActively participates in all regulatory and internal audits of the facilityPartner and manage relationships with ... of work and compliance with all company policies and regulatory guidelinesHelps improve metric performance to drive team results...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for driving customer impact by overseeing 5D efforts including Data, Diagnostics, Drug , Device, and Digital strategy and execution for relevant TAs, aligned closely ... Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs, Integrated Customer Engagement, Global and other relevant NNI… 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 ... optimization and efficient utilization of the warehouse space.Assist in regulatory inspections, perform safety and quality audits, and answer...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… more
- Genmab (NJ)
- …are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with the above ... other analyses not pre-defined in the SAP), answers to questions posed by regulatory authorities or ethics committees, answers to in-house questions related to data… more
- Eisai, Inc (Exton, PA)
- …focused on the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production ... groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible for the training of Manufacturing ... of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 US national… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is a plusStrong knowledge of GxP complianceExperience in cGMP regulatory body auditsStrong interpersonal and written/oral communication skillsAbility to quickly ... of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 US national… more
- Eisai, Inc (Nutley, NJ)
- …credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical industry, ... desired therapeutic area(s); comfortable and confident speaking about multiple drug indications/disease state management and competitor products and data.Understanding… more
