- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. Organization Overview: The Global CMC Regulatory Associate , Global Regulatory ... GRA- CMC RA Scientists, the various aspects of global marketing authorization submission management processes. The Associate...**Lead, Influence, Partner** + Create an environment within the Global Regulatory Area and across CMC… more
- Regeneron Pharmaceuticals (Troy, NY)
- …of global marketing applications. + Support the development and execution of CMC regulatory strategies for global markets. + Lead the preparation, ... (ROW) global submissions + Strong knowledge of CMC regulatory requirements and guidelines in ROW...determined based on qualifications relevant to the role. + Associate Manager: Requires 6+ years of relevant experience +… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Manager, CMC Regulatory Sciences for Clinical Submissions leads a team that manages the CMC regulatory submission work across multiple clinical ... programs and/or submissions. As a Manager, CMC Regulatory Sciences , a typical day...cross functional teams, contract manufacturing organizations, as well as global regulatory partners. + Oversees (in collaboration… more
- Regeneron Pharmaceuticals (Troy, NY)
- …effective systems for monitoring, analyzing, communicating, implementing, and influencing global regulatory and industry trends, regulations, and pharmacopoeia. ... The Director of CMC Industry and Regulatory Intelligence is...throughout IOPS + Monitors and assesses all sources of global CMC intelligence information, including industry trends,… more
- Amicus Therapeutics (Marlow, OK)
- …Quality Assurance . Ensure CMC development strategies are aligned with global regulatory expectations . Prepare submission package for Emerging Markets (One ... Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1290) Job Brief Associate Director CMC RA Amicus Therapeutics is a global ,… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. ** Associate Director** **; CMC , Device Development Program Manager** **Functional Area: ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical/oncology project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall … more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The EACD department develops new CMC paradigms for more effective and efficient NCE development and for advancement of NCE-like Alternative Medicinal ... Therapeutic Product (ATMP) projects. The Associate Director, Analytical/QC will be responsible for leading activities related to Analytical Development/Quality… more
- Organon & Co. (Plymouth Meeting, PA)
- … product and project regulatory strategies by ensuring robust assessment of CMC changes, identification of global regulatory requirements, and critical ... The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance… more
- AbbVie (Madison, NJ)
- …with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director, or Director, in ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager, Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison /… more
- Sanofi Group (Bridgewater, NJ)
- …+ Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory ... expertise to contribute to the definition of the global regulatory strategy, to enable and drive...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Sanofi Group (Bridgewater, NJ)
- …Leads the US regulatory post-marketing activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global ... expertise to contribute to the definition of the global regulatory strategy, to enable and drive...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Sumitomo Pharma (Columbus, OH)
- … Associate Director ensures compliance with GMPs, SMPA procedures and applicable global Regulatory guidelines by providing oversight and management of the ... contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates...for marketed pharmaceutical products or clinical trial materials. Review regulatory IND, IMPD, CTD and BLA/NDA CMC … more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Associate , Global External Manufacturing, Small Molecule Drug Substance ... and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …New Modality) team. - Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck (West Point, PA)
- …creative conflict resolution and problem-solving skill. + Strong knowledge of global regulatory guidelines and cGMP principles. + Demonstrated experience ... Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory - CMC , and Supply Chain. The end-to-end scope… more
- Merck (West Point, PA)
- …and influence process demonstration and qualification (PPQ) and shelf-life strategies. + Influence CMC regulatory strategy and author DP CMC sections of ... **Job Description** ** Associate Principal Scientist, Sterile Drug Product Commercialization** As...to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... to work independently and with cross-functional teams, including Materials Management, CMC , Regulatory , Quality, teams + Strong organizational, planning, and… more
- Novo Nordisk (Watertown, MA)
- …drug substance and resolve technical issues or deviations + Author and review relevant CMC sections for US and ex-US regulatory filings, including NDAs + Work ... a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while...Boston and will work closely with other functions of CMC drug development, including Drug Product, Analytical Sciences, Quality… more