- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience and… more
- Merck & Co. (Rahway, NJ)
- …Development, Procurement, Regulations, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , Regulatory Compliance, ... DescriptionThis position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to ... collate the necessary information to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality 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 the ... scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Merck (Austin, TX)
- …Development, Procurement, Regulations, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , Regulatory Compliance, ... This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more
- Fresenius Medical Center (Waltham, MA)
- …meet formatting, technical, and regulatory standards. + Collaborates cross-functionally with Regulatory Affairs , CMC , Medical Writing, Quality, and other ... in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory ...within Regulatory Operations for the preparation of regulatory submissions required to market new or existing licensed… more
- Lilly (Indianapolis, IN)
- …is to provide and maintain the interface between Product R&D Quality Assurance and Global Regulatory Affairs for CMC (GRACMC). + Ensuring that the internal ... preferably including QA batch release in a clinical trial environment, regulatory affairs ( CMC ), or clinical supply/material management **Additional… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum… more
- Rhythm Pharmaceuticals (Boston, MA)
- …stakeholders, including CMC Drug Substance, Supply Chain Management, Quality, and Regulatory Affairs . + Manages and executes activities related to drug ... will collaborate with partners in Supply Chain, Quality Assurance, Regulatory Affairs , Finance and various CRO/CMO's to...as required. + Authors and reviews relevant drug product CMC sections for global regulatory submissions (IND/CTA,… more
- Merck (Rahway, NJ)
- …Managers in Value & Implementation (which is this job), Development, and CMC ; Discovery Portfolio Managers; Alliance Managers; Project Management Office (PMO); and ... Administrative Professionals. **Position Description/Summary:** The GPAM Associate Director, Value & Implementation Project Manager (VIPM), is a core member of Value… more
- AbbVie (Cambridge, MA)
- …of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls ( CMC )). + Experience with ... ensure an in-depth understanding of the science behind each of these opportunities. The Associate Director, Search & Evaluation will be a key member of the Specialty… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Clinical Research and program management experience working with clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... Medical IISR clinical trials in assigned TA. Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from… more
- Amgen (Thousand Oaks, CA)
- …supply network and work with region's cross functional team (Commercial, Finance, Regulatory Affairs , Quality) to develop compliant product supply strategy for ... Life Cycle Management, Product Launches, Planning + Experience with Regulatory Affairs requirements, Clinical Development and/or International Business,… more
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