- Gilead Sciences, Inc. (Foster City, CA)
- …with any broader initiatives in this space across the enterprise. + Lead workforce capability design, training strategy , and upskilling initiatives. ... Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC requirements for drug… more
- Takeda Pharmaceuticals (Boston, MA)
- …contribute:** + Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy . + Guide the team to define ... and drive strategy for CMC regulatory dossier...Team lead role, prepares and maintains relevant regulatory documentation (eg, technical regulatory strategy… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... Regulatory Strategy ). + Assess and provide regulatory strategy for CMC technical...(NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead . + … more
- Taiho Oncology (Princeton, NJ)
- …CMC ) documentation for regulatory filings. + Experience in developing and implementing CMC regulatory strategy for early and late stage of development ... expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director,...will play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life… more
- BeOne Medicines (Emeryville, CA)
- …**Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for ... project + Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects. + Lead regulatory … more
- Sanofi Group (Morristown, NJ)
- …that model the Sanofi and GRA Values/Principles/Competencies. + Oversees the development of CMC regulatory strategy and regulatory risk assessments ... landscapes. With a commitment to Sanofi's "Take the Lead " values, particularly in "Leading Together" and "Being Bold,"...with FDA and EMA, so that appropriate and pragmatic Regulatory CMC positions are negotiated with the… more
- Takeda Pharmaceuticals (Boston, MA)
- …requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market ... Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and...rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities… more
- Takeda Pharmaceuticals (Lexington, MA)
- …manufacturing, quality, and regulatory frameworks, and how to apply these in CMC strategy and execution. + Demonstrated ability to lead complex, ... the role** Join us as our **Global Manufacturing Sciences CMC Lead ** and drive **high-impact, high-visibility ...global product and governance teams, driving clear decisions on CMC strategy , lifecycle management and technology excellence.… more
- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and ... clinical registrations, market application approvals, and post-approval lifecycle management. + Lead the preparation, review, and submission of regulatory … more
- Sanofi Group (Framingham, MA)
- …worldwide. Ready to get started? Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to ... + _Location: Morristown, NJ_ **About the Job** As GRA CMC Lead within our GRA CMC...drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle.… more
- Boehringer Ingelheim (Athens, GA)
- …small molecule and biologic drug development, analytical chemistry, formulation science, and regulatory CMC strategy . + Adept at integrating scientific ... regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC...vaccine products. The incumbent may serve as a Global Regulatory Project Lead within the project core… more
- Sanofi Group (Framingham, MA)
- … team member, ensuring data supports expedited pathways to clinic and patients + Lead CMC sub team (Dossier Subgroup or Submission Taskforce) for authoring, ... critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable...of science to improve people's lives. **Main Responsibilities:** + Lead , coordinate, and manage CMC dossier preparation… more
- Merck (West Point, PA)
- …challenges the product development team's strategy to ensure a robust CMC strategy is achieved. Identifies options to balance Speed/Cost/Robustness & achieve ... Team (DCT) leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target… more
- GE Aerospace (Evendale, OH)
- …developments and industry best practices. + **Strategic Contribution** : Contribute to strategy and policy development within the CMC Lean Lab, ensuring ... Process Engineer to join our team in Evendale, working in the CMC Lean Lab. This role combines tactical responsibilities with strategic contributions, focusing… more
- Bristol Myers Squibb (Indianapolis, IN)
- …contribute to shaping and advancing our Chemistry, Manufacturing, and Controls ( CMC ) strategy **Job Responsibilities** Essential duties and responsibilities ... We are seeking a highly motivated Sr. Scientist to lead the development and optimization of radiopharmaceutical drug products.... Author technical reports and source documents to support regulatory filing. . Author CMC sections for… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop ... is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local...for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Strategy Requisition ID: 7214 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the challenges are ... Opportunity - Open to candidates within the United States** The Director, US Regulatory Affairs Strategy , oversees the implementation of regulatory … more
- Gilead Sciences, Inc. (Washington, DC)
- …. **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure ... with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at… more
- Sumitomo Pharma (Honolulu, HI)
- …in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in ... position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory ...mentoring. **Job Duties and Responsibilities** + As a Regional Regulatory Lead , manage regional (United States, European… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships ... Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate...across Global Regulatory Strategy . Updates and maintains applicable … more