- Taiho Oncology (Princeton, NJ)
- …dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director, Regulatory CMC . Your expertise will ... play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life cycle and...With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology… more
- AbbVie (Florham Park, NJ)
- …Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal and external partners to deliver products to ... apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables. This individual prepares CMC… more
- Lilly (Philadelphia, PA)
- …life better for people around the world. **Position Overview:** The Director - CMC Regulatory will leverage CMC technical knowledge and regulatory science ... expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC … more
- J&J Family of Companies (Malvern, PA)
- …**We are searching for the best talent for a** **Distinguished Scientist, CMC Team Leader, Protein Conjugates** **to be located in** **Malvern, PA or ... Spring House, PA,** **Purpose:** Within the CMC group, you will lead multiple CMC Teams spanning from pre-NME through post-Approval, including Life Cycle… more
- Astellas Pharma (Northbrook, IL)
- …are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory ... frameworks and global CMC strategy. This role will lead the development and...Regulatory Affairs department for the Chemistry, Manufacturing and Controls ( CMC ) aspects of regulatory documents and submissions. Responsible for… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Description** **About the role** Join us as our **Global Manufacturing Sciences CMC Lead** and drive **high-impact, high-visibility CMC projects for innovative ... provide technical and strategic leadership for Chemistry, Manufacturing and Controls ( CMC ) of one or more late‑stage or commercial biopharmaceuticals with potential… more
- Sanofi Group (Waltham, MA)
- **Job Title:** CMC Dossier Leader **Location:** Framingham, MA/ Waltham, MA **About the Job** Join the engine of Sanofi's mission - where deep immunoscience meets ... could be critical in helping our teams accelerate progress. Join our CMC dossier Sciences team as CMC dossier leader and you'll contribute to the CMC … more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Building** + Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. + Own continuous improvement of the operating ... model and capability roadmap for the CMC RA function. + Creating and implementing functional business...strategic initiatives, centralize activities, and foster cross-functional support of CMC RA's processes, systems, data, and tools. + Define… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global CMC Automation and Robotics Leader **Location:** Framingham, MA or Cambridge, MA or Waltham, MA **About the Job** Are you ready to shape the ... possible. Ready to get started? Within Sanofi R&D, the CMC Data Sciences organization is a key enabler of...We are seeking a highly motivated and skilled Global CMC Automation & Robotics Leader. As a strong global… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Director, CMC provides leadership for the Chemistry, Manufacturing and Controls ( CMC ) function for Xeris' commercial and clinical/late-stage ... translates into skillful and competent application of knowledge to ensure the CMC function is in alignment with the Company's corporate and departmental goals.… more
- 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 medicine? The ... be critical in helping our teams accelerate progress. As GRA CMC Lead within our GRA CMC & GRA Device Organization, you'll drive global regulatory strategies for… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- AbbVie (North Chicago, IL)
- …third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality that are ... efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that...sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Solution Architect - RnD - In-Silico CMC **Location:** Morristown, NJ Cambridge, MA **About the Job** At Sanofi, we're committed to providing the ... team. Mostly dedicated to Digital In Silico Research & CMC Operations domain, you will be a key strategic...leaders to establish the Digital In Silico Research & CMC technology strategy, in alignment with Sanofi's Digital global… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior Manager of Statistics, you will provide ... in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an innovative and… more
- Organon & Co. (Jersey City, NJ)
- …Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing and implementing ... Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned small molecule products in accordance with global regulations and guidance, and Organon… more
- Parexel (Providence, RI)
- …highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's ... timely approvals and supporting continued market access. Key Responsibilities Strategic CMC Leadership * Provide regulatory strategy input for small molecules… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: CMC Project Manager** **Location: Cambridge, MA (Hybrid)** **About the role:** As a ... CMC Project Manager, you will provide project management expertise to CMC LCM activities for Takeda's small molecule portfolio. You will leverage technology… more
- UTMB Health (Webster, TX)
- Utilization Review Case Mgr - CMC - Clear Lake Center **Webster, Texas, United States** Nursing & Care Management UTMB Health Requisition # 2506588 The mission of ... **:** Utilization Management + Demonstrates thorough knowledge of Inter Qual Criteria, CMC Specialty Referral Guidelines and Protocols used to determine status for… more
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