- Sanofi Group (Morristown, NJ)
- **Job Title:** Head of Global Regulatory Affairs , CMC Small Molecule **Location:** Morristown, NJ **About the job** Join the engine of Sanofi's mission - ... turn the impossible into possible for millions. **Our Team/ Overview:** The Global Regulatory Affairs (GRA) CMC & Device Organization serves as a critical… more
- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... (PhD, PharmD, MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the pharmaceutical or biotech industry, with significant… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC , with significant experience in small molecules is ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing… 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
- Taiho Oncology (Princeton, NJ)
- …Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director, Regulatory CMC ... Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all...be required to perform other duties, as assigned. Job Details Job Family R&D Job Function Regulatory Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned ... strategy. + Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… 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
- Gilead Sciences, Inc. (Washington, DC)
- …degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas ... with an MA/MS, PhD, PharmD, or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies,… 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. Participates in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to… more
- Boehringer Ingelheim (Athens, 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
- AbbVie (North Chicago, IL)
- …such as analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs , supply chain and Operations ... is required. + Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, presentation,… more
- Sanofi Group (Waltham, MA)
- …automation + Experience with emerging digital technologies in pharmaceutical development and/or regulatory affairs + Skilled in AI applications and prompt ... critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable...leading the preparation of CMC dossiers for regulatory submissions to enable advancement of company's product development… 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
- Lilly (Indianapolis, IN)
- …with analytical R&D, process development, manufacturing science, quality, and regulatory affairs to standardize data products. **Deliverables include:** ... data products that power AI-driven insights, process optimization, and regulatory compliance. In this role, you'll bridge pharmaceutical sciences with… more
- Merck (Boston, MA)
- …on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs , clinical operations, and CMC teams. + ... implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert...robust study design and high-quality PET data collection. + ** Regulatory support** : Familiarity with regulatory and… 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
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Vice President of Regulatory Affairs will serve as the senior-most regulatory leader responsible for envisioning, developing, and executing ... post-marketing activities. Team Leadership * Lead, mentor, and retain a high-performing Regulatory Affairs team, including Regulatory Operations, Labeling,… more
- Takeda Pharmaceuticals (Boston, MA)
- …concepts into business terms. + Experience with regulatory domains such as Labeling, CMC , and broader Regulatory Affairs processes. + Exposure to public ... regulatory requirements (eg, IDMP, SPOR, XEVMPD, eCTD, ePI, PQ/ CMC , CTIS, ESMP) and assess their impact on RIM...or a related field** required. + Master's degree in ** Regulatory Affairs , Data Management, or related discipline**… more
- Parexel (Nashville, TN)
- …and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge ... to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as...in line with local legislation (renewals, PSURs, label updates, CMC changes). * Execute timely data entry and validation… more
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