- Lilly (Indianapolis, IN)
- …to make life better for people around the world. We are seeking an Advisor/Senior Advisor for Global Regulatory Affairs CMC to be a part of the Lilly ... Market Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs - CMC will leverage CMC technical knowledge… more
- Lilly (Indianapolis, IN)
- …market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... technical knowledge of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines for obtaining global product… more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. Grad Intern - Global Regulatory Affairs CMC **What You Will Do** Let's do ... change the world. During this program, you will work in the Global Regulatory Affairs Chemistry, Manufacture, and Controls ( CMC ) organization on the team… more
- Takeda Pharmaceuticals (Lexington, MA)
- …leadership experience (3+ years) required. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development ... where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval strategies for assigned products… more
- Lilly (Indianapolis, IN)
- …market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... of CMC drug development science(s) + Knowledge of bioproduct CMC global regulatory requirements and guidelines for conducting clinical trials and… more
- Takeda Pharmaceuticals (Boston, MA)
- …activities. Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report ... to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently plan, execute and manage regulatory submissions… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs , and CMC ... and inflammation, and serious respiratory and cardiovascular conditions. **Director, CMC Regulatory Affairs - Biologics**...+ Lead the execution and influence the development of global CMC regulatory strategies, including… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs , and CMC ... worldwide, with headquarters in Foster City, California. **Sr. Associate, CMC Regulatory Affairs - Biologics**... CMC submission experience. + Knowledge of global CMC regulatory landscape. +… more
- BeiGene (San Mateo, CA)
- …experience with a higher-level degree. **Experience:** + Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in ... **General Description:** + The Senior Manager, Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC … more
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director, CMC Regulatory Affairs . This position can be located in Spring House, PA; Horsham, PA; Titusville, ... development and commercialization. This person is responsible for developing global CMC regulatory strategies. The...product and is in alignment with the strategies of global regulatory affairs , the therapeutic… more
- Gilead Sciences, Inc. (Foster City, CA)
- … documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory ... project teams. + Develop, implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager.… more
- AbbVie (North Chicago, IL)
- …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... CMC on teams such as product development, Global Regulatory Product Teams and Operations brand...in initiatives internal to RA CMC . Represents CMC regulatory affairs on project… more
- Organon & Co. (Plymouth Meeting, PA)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse ... CMC documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and… more
- Organon & Co. (Plymouth Meeting, PA)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse ... Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal...strategy, Agency Background Packages, participating in Agency meetings on CMC topics, and executing global initial marketing… more
- BeiGene (San Mateo, CA)
- …aggressive timelines. The individual will provide support to cross-functional teams on regulatory CMC strategies. **Essential Functions of the job:** + Develop ... and implement small molecule regulatory CMC strategies as well as author...CMC experience with proven record of experience in global submissions for clinical trial/marketing applications and subsequent response… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** **Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs :** **_*This is a site based position located in ... analytical flexibility the incumbent will support "right first time" global approvals for CMC control strategies and...for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Regeneron Pharmaceuticals (Troy, NY)
- …organizational goals, and current policies + Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio of ... include:** + Direct activities of assigned Regulatory Affairs team with emphasis on global ...experience including a minimum of 5 years of relevant CMC Regulatory experience including experience in the… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Sr. CMC Regulatory Affairs Specialist... regulatory submissions to ensure all aspects of global regulatory and CMC compliance ... within the procedures and systems for enhanced tracking of global regulatory submission packages and approval status....experience, including a minimum of 3+ years of relevant CMC experience. Does this sound like you? Apply now… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …+ Participate in cross-functional meetings for program-specific discussions, proactively identify CMC regulatory issues and suggest appropriate strategies to ... Support CMC development activities from a regulatory ...of compliance tasks + Support preparations for interactions with global regulatory authorities (eg, meetings, IR responses,… more
- Merck (North Wales, PA)
- …Scientist / Director responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership ... commercial products. + In depth knowledge and application of global CMC guidelines regarding IND/BLAs or post...Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to… more
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