- Lilly (Indianapolis, IN)
- …for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the scientific and ... regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and...strategies for both development and commercial products. Additionally, the Senior Director is committed to fostering continuous… 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
- 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
- Boehringer Ingelheim (Ridgefield, CT)
- …of increasing regulatory complexity and/or business impact. The Senior Associate Director , US Product CMC Regulatory Affairs is responsible for the ... and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory ...concerning assigned US investigational and marketed product interactions. The Senior Associate Director position is expected to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** We are seeking a highly skilled and experienced Director to join our External Alternative CMC Development (EACD) team. The ideal candidate will ... external collaborations with Contract Development and Manufacturing Organizations (CDMOs). The Director will support all drug product-related CMC activities… more
- UTMB Health (Gatesville, TX)
- Regional Medical Director , CMC **Gatesville, Texas, United States** Physician UTMB Health Requisition # 2500313 The mission of Correctional Managed Care is to ... responsibility for all medical providers assigned within the region. Works under the director of the senior medical director . **_ESSENTIAL JOB FUNCTIONS_**… more
- Lilly (San Francisco, CA)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead (GRL) ... leadership assignments across multiple countries + Direct experience in clinical and CMC regulatory sciences + Knowledge of Global regulatory procedures and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of Pharm Sci CMC Governance Office:** Accountable for facilitating the Pharm Sci CMC Governance advisory board, comprised of senior -level CMC experts to ... top-tier development cycle times to accelerate drug to patients. **Accountabilities:** + Senior level R&D CMC portfolio strategy leader accountable for… more
- Ascendis Pharma (Palo Alto, CA)
- …Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area head for ... the US RA Strategy team. This role involves managing regulatory submissions and providing strategic leadership to ensure the...as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to… more
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