- 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)
- We are currently looking to fill a Commercial Post Approval CMC Regulatory Sciences Associate Manager position responsible for providing Chemistry, ... to mitigate risk. + Assisting in preparation for meetings with global regulatory authorities. + Contributing to developing CMC regulatory strategy. This… more
- Teva Pharmaceuticals (West Chester, PA)
- …difference, and new people to make a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help ... major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for...Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible for identifying… 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
- Regeneron Pharmaceuticals (Troy, NY)
- The CMC Regulatory Sciences Specialist position is...a typical day might include the following: + Prepares global CMC documents and sections for a ... for marketing applications, amendments, post approval variations, and other regulatory submissions. As a CMC Regulatory...risk. + May assist in preparation for meetings with global regulatory authorities. This role may be… more
- AbbVie (North Chicago, IL)
- …quality science, technology, deliverables, and collaborates to ensure compliance with global regulatory and quality requirements. Participates in meetings with ... and periodic reviews throughout development and in support of global filings and approvals. + Represents all CMC...safety and environmental requirements. Stay abreast of developments in global technical, regulatory and compliance arena and… 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
- 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
- Teva Pharmaceuticals (West Chester, PA)
- …of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global strategy. In addition you will ... Associate Director, Regulatory Affairs - Remote...will be responsible for acting as and supporting the Global Regulatory Lead (GRL) in strategic vision… 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
- Sanofi Group (Swiftwater, PA)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. ... **Our Team:** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical device, combination product, digital health and… 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …professionally to achieve your own career goals. **Job** **Title:** Scientific Associate Director **Location:** New Brunswick **Division:** Global Production & ... activities and will write or review microbiological sections of regulatory filings in compliance with current global ...biologic or pharmaceutical production + Direct experience with writing CMC Drug Product sections of regulatory filings… more
- Merck (West Point, PA)
- …and influences process demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP CMC ... **Job Description** **Position Description:** ** Associate Principal Scientist, Sterile Drug Product Commercialization** The Associate Principal Scientist is an… more