- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Commercial Post Approval CMC Regulatory Sciences Associate Manager position responsible for providing Chemistry, ... global regulatory authorities. + Contributing to developing CMC regulatory strategy. This role may be...medical device, including some supervisory and/or leadership experience. + Associate Manager : Requires 6+ years of relevant… more
- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is currently looking for a Manager for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory ... of world (ROW, ex-US/EU) initial marketing applications. As a Manager , CMC Regulatory Sciences, a...determined based on qualifications relevant to the role. + Associate Manager : Requires 6+ years of relevant… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Manager , CMC Regulatory Sciences...bachelors in Chemistry, Biology or related field, and + Associate Manager : Requires 6+ years of relevant ... regulatory submission work across multiple clinical programs and/or submissions. As a Manager , CMC Regulatory Sciences , a typical day might include the… more
- Teva Pharmaceuticals (West Chester, PA)
- …position comes with 4 direct reports (Dir, Sr Manager , Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible for ... at Teva (both development and marketed products) ⦁ Provide accurate and timely CMC regulatory guidance to teams engaged in the development of new products by… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. ** Associate Director** **; CMC , Device Development Program Manager ** **Functional Area: Technical Operations** At ... leadership role that collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and influential role in the… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager / Associate Director in CMC Development, located at our South San Francisco office. ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- AbbVie (Madison, NJ)
- …product(s) with multiple driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director, or Director, ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- Regeneron is currently looking for an Associate Project Manager to join our QC (Quality Control) AS (Analytical Sciences) team. The Associate Project ... and customer groups in a matrixed team environment, the Associate Project Manager ensures that analytical test...documents with impact to Analytical Sciences. + Collaborates with CMC Reg Sci to support regulatory filings… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. + ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Merck (Rahway, NJ)
- …the Research & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director, Project Manager , is a core member of Early ... **Job Description** The drug development Project Manager is part of Global Project and Alliance...strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and… more
- University of Colorado (Aurora, CO)
- QA Senior Manager - 33670 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Gates Biomanufacturing Center** **Job ... Title: QA Senior Manager ** **Position #: 00803572 - Requisition #:33670** **Job Summary:**...three direct and four indirect reports, including Quality Assurance Associate Is and IIs. + Recruit, supervise, develop, and… more
- Astellas Pharma (Sanford, NC)
- …MSAT, Process Engineering, Process Development, Quality Assurance, Process Sciences, Regulatory , CMC teams, Facilities, Validation, Supply Chain, Quality ... recommend new technologies that will enhance processes. **Organizational Context:** The Material Manager will report to the Associate Director, MSAT &… more
- Actalent (Paramus, NJ)
- Job Description: + Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies. + ... Controlled Drug experiences, etc. + Manage and processing of CMC Team project invoices and internal project budget requests...monitoring of project financial tracking. + Assist and support Regulatory Affairs (RA) to provide any documents for their… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). **A ... The **Sr Manager , Clinical Drug Supply & Logistics** is responsible...within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs /… more