- Merck & Co. (Upper Gwynedd, PA)
- …risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory ... are a plus.Preferred Experience and Skills: The ideal candidate will have experience in Regulatory CMC or in preparation of regulatory filings with technical… more
- Eisai, Inc (Exton, PA)
- …suites in a cGMP biopharmaceutical pilot plant, including scheduling of staff, preparation and close-out of documentation, manufacture of DS/ADI materials, and suite ... groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics… more
- Aequor (East Syracuse, NY)
- …issues.Identify new analytical technologies and opportunities for technical advancements.Support the preparation and review of regulatory submissions related to ... in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired.Experience authoring,… more
- Eisai, Inc (Nutley, NJ)
- …with creating, updating and maintaining project trackers in EPICProvides support for document preparation and follow-up (eg Informed Consent Form, eTMF fling ... action Item follow-upAttends CRO and vendor teleconferences as applicableReview regulatory packet for investigational product releaseProvide user access management… more
- Merck & Co. (Rahway, NJ)
- …. - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related ... the Clinical Supplies section of the study protocol as well as preparation and presentation of the clinical supplies information at Investigator Meetings for… more
- Robert Half Legal (Denver, CO)
- …Denver, Colorado. This role focuses on franchise law, supporting attorneys with regulatory compliance, document preparation , and state registration ... agreements and related documents. * Respond to state examiner comments and regulatory inquiries in collaboration with attorneys. * Conduct legal research on… more
- GE Vernova (Wilmington, NC)
- …(FMEA), probabilistic risk analysis (PRA), and similar techniques. + Support nuclear regulatory certification or licensing document preparation , + Perform ... Easy5/MSC, Simulink-MATLAB/MathWorks, Mathcad/PTC, 3KeyMaster/WSC, ETAP, SKM], + Change, configuration, document and bill of material (BOM) management [e.g.; ENOVIA/Dassault-Systemes].… more
- LA Care Health Plan (Los Angeles, CA)
- …with business units in audit universe preparation and validation. Assists in document preparation for regulatory and internal audits. Regulatory ... the guidelines and protocols to ensure readiness for all regulatory audits. This position will develop, with the assistance...the deficiencies. This position will be responsible for the regulatory obligations for each line of business and their… more
- Boehringer Ingelheim (Ridgefield, CT)
- …experienced CMC RA personnel, prepares cross-functional teams for FDA interactions on regulatory issues and provides guidance on preparation of briefing ... CMC and product labeling changes as well as the preparation and submission of original and/or supplemental applications and...sub teams in accordance with the CMC Functional Summary Document . + With minimal supervision, delivers US regulatory… more
- Sanofi Group (Morristown, NJ)
- …experience (regionally and/or global) + Significant track record of US regulatory expertise required (demonstrated experience with preparation of BLA/NDA, ... **Job Title:** Regulatory Strategist - mRNA Vaccines **Location** : Swiftwater,...team members. This includes the authoring of the briefing document focused on the strategy and scientific content, and… more
- Chiesi (Cary, NC)
- …development and implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation , launch prep, review, approval, and ... regulatory guidance documents and initiating changes in systems to ensure regulatory compliance. Knowledge of Common Technical Document and global guidelines… more
- Exelon (Mays Landing, NJ)
- … initiatives and key filings. 3. Apply critical analytical skills in the preparation of regulatory data filing requirements for distribution rate case ... reports for management (25%) + Provide data and support for the preparation of written testimony, regulatory audits and post-filing implementation requirement… more
- Vistra (Irving, TX)
- …other operations functions. May also interact with personnel associated with external regulatory agencies. Maintain regulatory document management system and ... **Education, Experience, and Skill Requirements** + 0-1 years experience in compliance, regulatory , project management, document management, or related areas. +… more
- LSI Solutions (Victor, NY)
- …will possess strong administrative skills, including proficiency in Microsoft Office, document preparation , and organizing and maintaining a master scheduling ... + All essential functions listed above. + Locate all regulatory certificates. + Independently generate document change requests as needed. + Assist in review and… more
- Robert Half Office Team (Erlanger, KY)
- …shipping, adhering to quality and regulatory standards. * Assist in document preparation and management, including scanning and sorting. * Handle clerical ... duties with high attention to detail to meet operational needs. * Collaborate with team members to ensure deadlines are met and client requirements are fulfilled. * Maintain orderly filing systems to support easy retrieval of information. * Ensure compliance… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is on to ... accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global...their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading… more
- Merck (Upper Gwynedd, PA)
- …+ Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects. + Provide regulatory ... plus. **Preferred Experience and Skills:** + The ideal candidate will have experience in Regulatory CMC or in preparation of regulatory filings with… more
- Hologic (Newark, DE)
- …and confidence. The Regulatory Affairs Specialist 4 performs the coordination and preparation of document packages for regulatory submissions for new and ... activities associated with warning letter remediation efforts including the preparation and compiling of documentation packages for regulatory submissions,… more
- Ameren (Steedman, MO)
- …to regular full-time employees. Job Description **About The Position** The Regulatory Affairs / Licensing Engineer provides support to the Callaway Energy Center ... in the areas of regulatory and licensing issues. **Key responsibilities include** ...defense of licensing positions with the NRC. + Coordinate preparation of submittals to change or amend the Callaway… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
