- Merck & Co. (Rahway, NJ)
- … Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions , Strategic Thinking, Systems ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Merck & Co. (Upper Gwynedd, PA)
- …Compliance, Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory Submissions , Technical Writing-Preferred ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Eisai, Inc (Nutley, NJ)
- …and objectives of the Business Group for these programs as related to regulatory submissions and milestones including interactions with Health Authorities. This ... to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the...Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post… more
- Genmab (NJ)
- …relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory submissions including BLAs and previous experience in dealing ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Merck & Co. (North Wales, PA)
- …to designing and analyzing clinical trials in support of worldwide regulatory submissions .This position involves interaction with Medical, Data Coordination, ... Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions , Scientific Modeling,… more
- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (South San Francisco, CA)
- …to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions .The candidate will play a key role in developing, ... ability to influence scientists to adapt to positive change. -Experience with regulatory submissions and understanding of the review process. -Familiarity with… more
- Merck & Co. (Rahway, NJ)
- …our Company and with external suppliersAuthor and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product ... in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead… more
- Formation Bio (New York, NY)
- …global regulatory expectations (eg, FDA, EMA, ICH); author and review regulatory submissions including INDs, BLAs, and other key documents. Continuous ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… 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 ... 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)
- …with late-stage process development, process characterization, process validation regulatory submissions , and working with external contract ... Process Validation, Manufacturing Scale-Up, Mentorship, Process Improvements, Protein Purifications, Regulatory Submissions , Social Collaboration, Statistical Design of… more
- Insmed Incorporated (San Diego, CA)
- …solid experience supporting Phases I-IV (particularly Phase III); experience with Regulatory submissions and/or approval. Experience with gene therapy products ... of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy… more
- Aequor (East Syracuse, NY)
- …and opportunities for technical advancements.Support the preparation and review of regulatory submissions related to analytical procedures, method development ... in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired.Experience authoring,… more
- Tris Pharma (Monmouth Junction, NJ)
- …cGMPs and SOPs Evaluates compendial methods and procedures, as neededPrepares regulatory submissions ; Executes studies and prepares technical protocols/reports ... in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs),… more
- Merck & Co. (Rahway, NJ)
- …function areas. Primary Activities :Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures ... and associated documentationEnsure programmatic traceability from data source to analysis/modeling resultSupport the development of programming standards to enable efficient and high-quality production of programming deliverablesProvide technical consultation… more
- Twist BioScience (South San Francisco, CA)
- …and security of all manufacturing data within the MES, critical for regulatory submissions and audit trails. Develop and implement robust reporting, ... of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our… more
- Merck & Co. (Rahway, NJ)
- …covariate data.Produce tables and graphics for inclusion in study reports and regulatory submissions .Produce SAS transport files and associated documentation for ... regulatory submissions .Assure deliverable quality and compliance with departmental SOPs and good programming practices.Collaborate effectively with project team… more
- Aequor (Pearl River, LA)
- …results and present at team meetings. Write research reports to support regulatory submissions . Read scientific and technical literature to stay current ... in the field and to bring new and improved technologies to the laboratory. Maintain laboratory notebooks in compliance with the Laboratory Notebook Policy. Stay current on all departmental and corporate training. Perform other duties as assigned.… more
- Formation Bio (New York, NY)
- …complex imaging analytics to diverse stakeholders Preferred Qualifications Experience with regulatory submissions involving imaging endpoints or AI-based image ... to integrate imaging AI solutions into trial protocols and workflows Partner with regulatory teams to ensure imaging biomarkers and AI models meet FDA standards for… more
- Genmab (NJ)
- …Health Authority briefing documents and responses, and clinical modules of regulatory submissions (eg, NDA, BLA, MAA).Drive collaboration with cross-functional ... the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a...of high-quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help… more
