- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead ... + MD **Preferred Qualifications** + Has 5+ years of relevant experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.… more
- Amgen (Holly Springs, NC)
- The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for ... manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop solutions to… more
- 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 ... and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and...**Operational Excellence Departmental Process Management** + Partners with other GRA- CMC Sr . Directors to ensure that internal… 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
- AbbVie (North Chicago, IL)
- …. Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… more
- Boehringer Ingelheim (Ridgefield, CT)
- … complexity and/or business impact. The Senior Associate Director, US Product CMC Regulatory Affairs is responsible for the direction, coordination and ... lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible...relevant topics. Additionally, with support and guidance from the Sr . Associate Director / Director, acts as liaison to… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... guide the team to define and drive strategy for CMC regulatory dossier content and reviews this...timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality… more
- BeOne Medicines (Harrisburg, PA)
- …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory … more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Sr . Scientist, Regulatory Affairs CMC will implement regulatory Chemistry, Manufacturing, & Controls ( CMC ... Prepare and review of information required for development of Regulatory CMC dossiers for projects and products including clinical development, original… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and… more
- AbbVie (Irvine, CA)
- …as analytical, microbiology, device engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs , supply chain and Operations ... analytical, microbiology, device engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs , supply chain and Operations… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... a state-of-the-art analytical laboratory + Guide the authoring, review and approval of CMC sections in regulatory filings, and support interactions with health… more
- Vera Therapeutics (Brisbane, CA)
- …including Research, Clinical Pharm, Analytical Science, Drug product, Quality Assurance, Regulatory Affairs , Supply chain, Finance, and Program Management. Write ... Title: Senior Manager, Early-Stage Biologics Development, CMC ...teams. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. Qualifications: *… more
- Merck (North Wales, PA)
- …in pharmaceutical or combination product research, development and/or manufacturing + Experience with CMC regulatory where drug is the primary mode of action ... Support device design control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices and combination products,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Sumitomo Pharma (Frankfort, KY)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager, Regulatory Affairs ** . The Senior Manager ... is part of the Global Regulatory Affairs (GRA) team based in the US and he/she...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Ascendis Pharma (Palo Alto, CA)
- …United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr . Director, Regulatory Affairs will serve as the therapeutic ... trials as well as Life Cycle Management Strategies. The Sr . Director will work closely with the executive team...devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) ... and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructivelychallengeteams to reachthebest solutions… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Pharmacology, Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC , Regulatory Affairs , Patient Safety and ... authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In addition, integrated safety assessments may also… more
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