- Insmed Incorporated (NJ)
- …patients, for each other, and for the future of science, we're in. Are you?About the Role:The Sr . Director CMC QA will lead QA CMC oversight for drug ... of deviations, CAPAs, change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory , Clinical Operations, and Program… 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 ... promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr . Director of Toxicology as part of the Clinical Development team… more
- 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
- 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 ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for...therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams ( CMC ,… 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
- 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
- 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
- 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
- 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
- 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
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) ... Industry-relatedexperiencein regulatoryaffairsand/ordrugdevelopmentexperiencefor 10years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable… 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
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
- Takeda Pharmaceuticals (Lexington, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
- Lilly (Indianapolis, IN)
- …of life saving therapeutics. **Role Overview:** We are seeking a veteran and visionary Sr . Director of Early Phase Chemistry to join our leadership team. This ... lifecycle of an asset ranging from the discovery/development interface through regulatory submission and post-approval changes. We work to improve patient outcomes… more
- ThermoFisher Scientific (Greenville, NC)
- …Experience** **(You MUST show the above in your submittal to be considered)** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher Scientific, you'll ... general medicine and vaccines. **Discover Impactful Work:** We are seeking a ** Senior Director , Project Management** in our **Non-Interventional Oversight Team… more
- ThermoFisher Scientific (Greenville, NC)
- …gaining cross-cultural experience. **Discover Impactful Work:** We are seeking a ** Senior Director , Project Management** in our **Oversight Respiratory Trials ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Manager, Supply Chain leads, develops, establishes, and manages the supply chain ... development, distribution, importation, export, and vendor management in cooperation with Director of Commercial Supply Chain. This incumbent will drive supply chain… more
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