- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. ... organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad… 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 ... regulations and guidances, and is-responsible for the preparation and submission of CMC dossiers for all assigned development products. -Primary responsibilities… 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 ... 10+ years of experience in the biopharmaceutical industry, with deep expertise in CMC development for biologics. Prior experience in a leadership role within… more
- Merck & Co. (Rahway, NJ)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... organizations ( our Manufacturing Division / our Research & Development Division ) such as Quality, Regulatory CMC...mindset and collaboration with various partners and stakeholders in development .The Director will report to the Executive… more
- Merck & Co. (Rahway, NJ)
- … development process & connectivity between functions supporting pipeline (ie clinical development , CMC , supply chain, & human health), and balancing needs of ... clinical supply chain across the full Company's Research & Development Division portfolio of clinical trial s .- GCS...as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical… more
- Merck & Co. (Rahway, NJ)
- …late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics ... portfolio of approximately 3-6 programs at various stages of development . The key accountabilities include managing the work and...The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in… 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 ... + A scientific degree with directly relevant professional experience in biologics product development , global CMC regulatory affairs, and CMC technical areas… more
- Boehringer Ingelheim (Ridgefield, CT)
- …position can support projects of increasing regulatory complexity and/or business impact. The Senior Associate Director , US Product CMC Regulatory Affairs is ... relevant topics. Additionally, with support and guidance from the Sr . Associate Director / Director ,...DMF Annual Report on behalf of the DMF Holder. CMC Development : + Provides US CMC… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages ... strategies for both development and commercial products. Additionally, the Senior Director is committed to encouraging continuous improvement in regulatory… more
- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage ... based upon global regulatory changes. + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product… more
- Lilly (Indianapolis, IN)
- …a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval ... life-changing new medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - … more
- Takeda Pharmaceuticals (Lexington, MA)
- …proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global drug development and post-market ... This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical… more
- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This ... and Marketing Authorization Application (MAA) submissions + Lead the development and execution of global CMC regulatory...care resources. Other perks like tuition reimbursement and a recognition program. If you come across a role that… more
- BeOne Medicines (Emeryville, CA)
- …of relevant pharmaceutical or biopharmaceutical industry experience in innovative drug CMC development , manufacturing, Quality, etc. including minimum 8 years ... team in US. * Lead or/and oversee the development and implementation of biologics regulatory CMC ...needed throughout product lifecycle. Escalate the critical issues to senior management timely. * Lead or/and oversee the establishment… more
- Takeda Pharmaceuticals (Boston, MA)
- …part 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...oversee the development and execution of regulatory CMC development and registration strategies. You will… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidances, comments on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more
- BeOne Medicines (San Mateo, CA)
- …critical issues to senior management timely. + Lead or contribute to development of internal small molecule CMC regulatory guidance and working + ... consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory… more
- Lilly (Indianapolis, IN)
- …development cycle (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected ... life better for people around the world. The Synthetic Molecule Design and Development (SMDD) is responsible for the development of synthetic drug substances… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to ... assigned therapeutic area. The GRL is the accountable decision maker for the development & execution of global regulatory strategies from portfolio entry to end of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …relevant industry experience + Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug ... their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all… more