- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the scientific ... processes. + Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials,… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs Chemistry, Manufacturing and Controls ( CMC ) works ... areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global... CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to… 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 ... and response to regulatory health authorities. + Leads the development of global CMC regulatory science-based strategies for internal RCM oncology… more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality ... Assurance develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Insight Global (Conshohocken, PA)
- Job Description A growing pharmaceutical company is seeking a Compliance GXP Associate Director to join their IT organization. The role requires a seasoned ... cross-functionally within the IT organization and with departments such as Quality, R&D, CMC , Legal, HR, and Finance to ensure compliant operation of IT systems. Key… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr. Manager/ Associate Director , Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... The position is responsible for a managing all aspects of global Contract Manufacturing partnerships, driving productivity through strategic initiatives with… more
- Rhythm Pharmaceuticals (Boston, MA)
- …experienced and highly motivated individual to join its team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product small ... CAPAs as required. + Authors and reviews relevant drug product CMC sections for global regulatory submissions (IND/CTA, NDA, MAA etc). Qualifications and Skills… more
- Bristol Myers Squibb (Seattle, WA)
- …Read more: careers.bms.com/working-with-us . **Position Summary:** The energetic and motivated Associate Director will leverage their technical and operational ... to interpret results and communicate with process development engineers and CMC teams. Excellent communication and organization skills are required, and the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** ** Associate Director , Clinical Research, Value & Evidence Generation, US Medical** ... cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function. Clinical Science experience… more
- RTX Corporation (Pueblo, CO)
- …**Security Clearance:** None/Not Required Collins Aerospace is seeking an experienced Associate Director of Carbon Engineering (AD-CE). This position reports ... directly to the Director of Carbon Engineering in Pueblo, CO. This role...Springs, CA. The three sites are referred to as Associate Manufacturing Facilities (AMF) as part of Troy, OH… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …+ Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small ... while balancing business benefits and risks. + Lead and Manage Global Submission Activities: Oversee submission planning, authoring, reviewing, and coordination for… more
- Sumitomo Pharma (Nashville, TN)
- …Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will… more
- AbbVie (Cambridge, MA)
- …to 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 ... group is part of the Corporate Strategy Office and actively supports global Business Development (BD) goals by sourcing and assessing external partnering… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Associate Director , Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology ... cross-functional teams such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc. Responsibilities will include planning and reviewing study designs… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... Join our global diversified pharmaceutical company enriching lives through our...product/dossier management lifecycle, including Development, Promotion and Advertising, Labeling, CMC , Commercialization, and Operations + Knowledge of domestic and… more
- Sanofi Group (Cambridge, MA)
- …experience. The successful candidate will work in a cutting-edge scientific global crystallization department in Sanofi's R&D CMC Synthetic organization. ... **About the Job** We are an innovative global healthcare company with one purpose: to chase...(Digital Twins) for batch and continuous process and use Global System Analysis tools (eg gPROMS) to identify CPPs,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to collate the necessary information to… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work ... Overview:** We are seeking a veteran and visionary Sr. Director of Early Phase Chemistry to join our leadership...programs at CDMOs. This role will report to the Associate Vice President in SMDD. **Key Responsibilities** _People &… more
- Takeda Pharmaceuticals (Exton, PA)
- …of my knowledge. **Job Description** **About the role:** Join Takeda as a Director , US Medical Clinical Research - Medical Engagement & Innovation where you will ... Medical Affairs team, you will report to the Sr. Director & Head, US Medical Clinical Science, Clinical Research...study strategic vision and remit for study team, coaches Associate Directors and Clinical Sr/Research Managers. + Assurance of… more
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