- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... drug approvals through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC… more
- Lilly (Indianapolis, IN)
- …patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to… 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 ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- AbbVie (North Chicago, IL)
- …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... department. Leads initiatives internal to RA CMC . + Represents CMC regulatory affairs on project initiatives with other functional areas to drive… more
- Parexel (Providence, RI)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our ... in developing contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional project meetings and provide … more
- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies ... strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams… more
- Gilead Sciences, Inc. (Foster City, CA)
- …operating seamlessly connected with the broader enterprise. + Partner with Regulatory Affairs , Quality, Technical Development, and Manufacturing stakeholders to ... roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. + Own continuous...regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC … more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately ... for Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA and other Health Authorities. +… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing and ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more
- ThermoFisher Scientific (Grand Island, NY)
- …Chemistry, or related field; advanced degree preferred + 7 years of experience in CMC regulatory affairs within the pharmaceutical industry + 1+ year ... (GMP) Safety Standards, Office **Job Description** The Sr. Manager, Regulatory Affairs - Drug Support Strategy is...regulatory standards + Provide strategic mentorship on applicable CMC regulatory submissions and support for customers… more
- Actalent (Lake Forest, CA)
- …Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device, Regulatory affairs , FDA CFR, CMC , manufacturing controls, RAC ... Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global...Additional Skills & Qualifications Advanced Engineering Degree a PLUS CMC (Chemistry, Manufacturing, and Controls) experience is a plus… more
- Boehringer Ingelheim (Duluth, GA)
- …marketed product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC ) function for pharmaceutical ... + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on... standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and Teva Standard Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs , CMC , Biostatistics, GCO, in the execution ... Lead, Clinical Scientist. and other functional areas such as GCO, biostats, regulatory , pharmacovigilance. The Director will be a key contributor to INDs, NDAs,… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **The purpose of the CMC Regulatory Quality Advisor role is to be the quality expert for their ... team.** **Primary Responsibilities:** **This position provides direct quality support to Global Regulatory Affairs (GRA), with a primary focus on the Chemistry,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus of Gilead ... an Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs or closely related subject. The...summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... analytical deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate… more
- Takeda Pharmaceuticals (Boston, MA)
- …with functional areas from quality, process experts, product experts, device experts, and regulatory affairs . + Works with supervisor for alignment on project ... application is true to the best of my knowledge. **Job Description** **Title: CMC Project Manager** **Location: Cambridge, MA (Hybrid)** **About the role:** As a … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Sumitomo Pharma (Lincoln, NE)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the...Global Regulatory Affairs (GRA) team based in the US. He/She will...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
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