- Bristol Myers Squibb (New Brunswick, NJ)
- …aspects of global change management. **Position Summary / Objective** The CMC Regulatory Associate Director, Biologics is responsible for content ... in their personal lives. Read more: careers.bms.com/working-with-us . The CMC Regulatory Associate Director, Biologics... Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. ... Join Gilead and help create possible, together. **Job Description** The Associate Director, Analytical Regulatory Science, collaborates with product development,… 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
- 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
- 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
- AbbVie (North Chicago, IL)
- …development, quality and analytics is required. + Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. Ability to ... influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, presentation, and overall communication. +… 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
- Kelly Services (Juncos, PR)
- **Sr. Associate Regulatory Affairs, PR** **(Administrative shift)** **At Kelly** **(R)** **Science, Engineering, Technology & Telecom (SETT), we're passionate ... you. How about this one?** **We're seeking a Sr. Associate Regulatory Affairs to work with one...the job that's just right.** **Responsibilities:** + Support site Regulatory Affairs ("RA") CMC staff, collaborate 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
- Allogene (South San Francisco, CA)
- …include: * Assist in the authoring, submission, and maintenance of global regulatory submissions related to clinical, CMC and nonclinical aspects of product ... (formerly Twitter) and LinkedIn. About the role: The Senior Associate will support all aspects of regulatory ...* Strong knowledge of eCTD elements and structure including CMC . * Ability to work in a fast-paced, start-up… more
- Sanofi Group (Cambridge, MA)
- **Job title: Device Regulatory Lead ( Associate Director)** + Location:...The team is part of the Global Regulatory Affairs, Regulatory CMC and ... Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical… more
- Bristol Myers Squibb (Devens, MA)
- …specifications, reference standards, and comparability studies. In addition, the ASL Associate Director will be accountable for enabling regulatory filings ... in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** ASL Associate Director, Analytical Strategy & Lifecycle Group Lead **Location** :… more
- Takeda Pharmaceuticals (Boston, MA)
- …Development, Drug Product Development, and adjacent functions (such as QC, QA, CMC regulatory affairs, clinical supply chain) with full accountability for ... Research (PR) group within Synthetic Molecule Process Development (SMPD) is a global team responsible for interfacing with Takeda's Discovery functions (eg medicinal… 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
- Teva Pharmaceuticals (West Chester, PA)
- …in a matrix team to progress biologic products. + Experience authoring and reviewing regulatory submissions related to CMC activities. + Current knowledge of ... Associate Director, Drug Product Development Date: May 24,...people to make a difference with. **The opportunity** Teva's Global Research & Development (R&D) organization is devoted to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team… more