- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA… more
- Merck & Co. (Upper Gwynedd, PA)
- …Principal Scientist, CMC , R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/ Sr Principal Scientist in Pre-approval ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... regulatory leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products,… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Division / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC , Statistical Design of Experiments (DOE),… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate...as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical… 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
- Eli Lilly and Company (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
- nChroma Bio (Boston, MA)
- …and breakthrough medicines. ABOUT THE ROLE nChroma Bio is seeking a Senior Director , Analytical Development/Quality Control to drive the strategic development ... related to QC. The candidate's ability to represent the AD/QC function in Regulatory CMC meetings and drafting the Module 3/IB documents is a must. Candidate… more
- Vaxcyte (San Carlos, CA)
- …the Director will be a part of the Global MSAT organization reporting to the Sr . Director of Process Validation. This role will be immersed in all aspects of ... safety and compliance of validation activities including support for regulatory filing, inspection, and other CMC and...and push the boundaries within the industry. Reports to: Sr . Director , Process Validation Location: San Carlos,… more
- Neurocrine Biosciences, Inc. (San Diego, CA)
- …project teams (including clinical operations, preclinical/clinical pharmacology, biometrics, regulatory , drug safety, CMC ). Responsible for medical ... Facebook. (*in collaboration with AbbVie) About the Role: The Executive Medical Director will be primarily responsible for developing and executing the Neurology… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). Minimum of 5 years' experience as a… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. You… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing...care resources. Other perks like tuition reimbursement and a recognition program. If you come across a role that… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the scientific and ... regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and...strategies for both development and commercial products. Additionally, the Senior Director is committed to encouraging continuous… 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
- Boehringer Ingelheim (Ridgefield, CT)
- …of increasing regulatory complexity and/or business impact. The Senior Associate Director , US Product CMC Regulatory Affairs is responsible for the ... and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory ...relevant topics. Additionally, with support and guidance from the Sr . Associate Director / Director ,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …DESCRIPTION** + Leads a team of CMC RA colleagues to drive global CMC regulatory strategy development for a portfolio of projects from early development ... through the early years of commercialization. + Leads the execution of global CMC regulatory plans, including overseeing the submission preparation process in… more
- BeOne Medicines (Emeryville, CA)
- …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory … more
- Gilead Sciences, Inc. (Foster City, CA)
- …on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides advice and ... with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with… more
