- Fresenius Medical Center (Waltham, MA)
- …considerations into all stages of product development, including preclinical, clinical/medical, CMC , and post-market phases. + Monitor regulatory trends, ... AND SCOPE:** Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays a… more
- BeOne Medicines (Cambridge, MA)
- …and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical Operations to understand ... and managing external partnerships and relations; (3) comprehensive global pharmaceutical regulatory requirements (cGMP, GDP, and GCP); (4) IRT system setup and… more
- Deloitte (Boston, MA)
- …experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and ... automation for pharmaceutical regulatory content or regulatory intelligence; Veeva RIM...generating submissions packages + Experience with submissions management, labeling, CMC change control and/or LCM processes + Understanding of… more
- Cambrex High Point (Waltham, MA)
- …+ Author and review process development reports, batch records, validation protocols, CMC documentation (eg, Module 3), and regulatory filings (IND, NDA). ... + Collaborate cross-functionally with QA, QC, regulatory , and supply chain to ensure technical alignment and compliance. + Troubleshoot scale-up issues, support… more
- Cytel (Cambridge, MA)
- …Bayesian analysis experience and had exposure to Chemistry, Manufacturing, and Controls ( CMC ) data analysis. You are excited and enthusiastic, motivate your teams to ... **Position Overview:** We are seeking a highly motivated Biostatistician to support CMC projects across the drug development lifecycle. The ideal candidate will have… more
- Takeda Pharmaceuticals (Boston, MA)
- …Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require ... as functional expert in divisional and cross-divisional initiatives. + Represents CMC on cross-divisional governance and development teams while providing strategy… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …portfolio/network rationalization for Global Manufacturing and Supply (GMS). As part of CMC team conduct due diligence for inbound opportunities in support of Global ... or showstoppers, verify alignment with Takeda's technology, network, business, and regulatory strategies, assess capabilities fit, ensure timeline vs. deal value… more
- Sanofi Group (Cambridge, MA)
- …toward all GPT members, including eg project management, clinical operations, regulatory , safety, translational medicine, statistics, CMC , IA **Basic ... The GPH will be delegated such responsibilities as interaction with regulatory /health authorities (HA), approval of documents and product label, as appropriate.… more
- AbbVie (Worcester, MA)
- …policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and ... Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and PDS&T to ensure alignment Responsibilities + Support… more