- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing ... INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC ...NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …and consultants, and will involve significant coordination/collaboration with Technical Operations, Regulatory CMC , Commercial, Legal (both IP and Contracts), ... leadership of this team in a matrix fashion for CMC . The position has high accountability and visibility in...of both large and small molecules and the associated regulatory approval processes and challenges. Knowledge of global requirements… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …Please visit www.jazzpharmaceuticals.com for more information. Brief Description: The Senior Director , Drug Product Development provides scientific and ... dosage forms, and potential novel combination products (ie, drug-device). The Senior Director , Drug Product Development is responsible for overseeing… more
- Insmed Incorporated (San Diego, CA)
- …each other, and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on ... leadership within gene therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams ( CMC , clinical and project… more
- Formation Bio (New York, NY)
- …where you will work closely with our business development, legal, clinical, CMC , and data/engineering teams to on-board products with strong IP potential, and ... thereafter coordinate patent and regulatory activities to deliver best-in-class IP positions. We expect this person to create and influence strategy, assist with… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... commercial strategy.Collaborate closely with internal functions such as Pharmacology, CMC , Regulatory Affairs, Clinical, and Program Management.Maintain… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in...tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting,… more
- Endo International (Horsham, PA)
- …we serve live their best life. **Job Description Summary** The Associate Director , Manufacturing Operations will provide leadership and management of operations at ... including Upstream Processing, Downstream Processing, and Manufacturing Support. The Associate Director is a member of the site leadership team and works… more
- BeOne Medicines (San Mateo, CA)
- …Clinical Development, Clinical Operations, Global Statistics & Data Science, Safety, Regulatory , CMC , Portfolio). + Hands-on experience with modern data ... As Director of R&D Data Enablement / Data Products,...chain. By collaborating with stakeholders across Research, Clinical, Safety, Regulatory , Portfolio & Project Management and other R&D functions,… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **:** The Manager, Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for ... provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC , and … more
- CSL Behring (Waltham, MA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . -Applies the CSL Leadership Capabilities - Build Bridges, ... a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? The...days a week. You will report to the Executive Director Head Regulatory . **Position Description** **Summary** -… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC technical ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to… more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial ... that make life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Boehringer Ingelheim (Ridgefield, CT)
- …is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... the project(s), in support of CMC development within EACD. The Associate Director / Senior Associate Director of EACD for drug product develops… more
- Amgen (Washington, DC)
- …statistical modeling for CMC development and commercial support. Reporting to the Senior Director , CMC Statistics, you will drive innovation in kinetic ... team. Join us and transform the lives of patients while transforming your career. ** Director , CMC Modeling & Advanced Statistics** **What you will do** Let's do… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… more
- Sumitomo Pharma (Lincoln, NE)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is… more
- Sumitomo Pharma (Boise, ID)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects.… more
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