- 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
- 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)
- …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
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions .-Under the general scientific and administrative direction ... risk assessment (RA), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA etc.).Adaptability and agility to prioritize… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …multiple therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills ... this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced experience working on Phase I-IV… 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
- Merck & Co. (North Wales, PA)
- …the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… 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
- 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
- Insmed Incorporated (San Diego, CA)
- …and procedures suitable for inclusion in IND, NDA, or equivalent regulatory submissions .Must be familiar with BSL-II lab safety requirements.Participate ... including interpretation of results and reporting that stands up to regulatory inspection.Demonstrated expert knowledge of scale-up principles with respect to viral… more
- Merck & Co. (Rahway, NJ)
- …in other related function areas. Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures ... and associated documentation.Ensure programmatic traceability from data source to analysis/modeling result. Support the development of programming standards to enable efficient and high-quality production of programming deliverables.Educational… more
- Merck & Co. (Rahway, NJ)
- …technologies.Proven track record of authoring and providing critical input to the regulatory submissions including but not limited to Investigational New Drugs, ... development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising,… more
- Aequor (South San Francisco, CA)
- …scientific results that support the generation of publications, patents, or regulatory submissions and mentoring research associates and laboratory assistants. ... Preferred Qualifications A focus on kinetics and binding affinity characterization with experience using Carterra Biacore SPR and/or Sartorius BLI instruments. Proven track record of academic accomplishments (ie, peer-reviewed publications and/or patents)… more
