- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA… more
- Merck & Co. (North Wales, PA)
- …and negotiate with key c ross functional Leaders is critical. Th e Senior Director should have strong managerial experience, a high-level strategic understanding ... Job DescriptionReporting to the Executive Director , RIIM , this role will be accountable...this role will be accountable to ensure a holistic Regulatory centric D ata M anagement ( R DM)… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , DCT Leadership position in our company's Manufacturing Division is a dedicated full-time role and is accountable for leading the DCT at ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- 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
- 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 ...relevant topics. Additionally, with support and guidance from the Sr . Associate Director / Director ,… more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial ... that make life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new… more
- BeOne Medicines (San Mateo, CA)
- …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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... experience and 4+ years direct or related CMC regulatory experience + Successful track record in preparation, management of review and approval of NDA/MAA/BLA… 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
- AbbVie (North Chicago, IL)
- …robust measurement frameworks to deliver business value with data-driven insights to senior leaders. + Preferred background with Biologics CMC (proteins, ... Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Biologics CMC , a part of Development Sciences within AbbVie's R&D, is a… 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) ... Industry-relatedexperiencein regulatoryaffairsand/ordrugdevelopmentexperiencefor 10years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable… more
- Sanofi Group (Cambridge, MA)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research ... **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and...Affairs Device Head, Specialty Care Device and Combination Products ( Sr . Director ) **Location** : Cambridge, MA or… more
- Merck (Rahway, NJ)
- …to influence and negotiate with key cross functional Leaders is critical. The Senior Director should have strong managerial experience, a high-level strategic ... **Job Description** Reporting to the Executive Director , RIIM, this role will be accountable to...Regulatory Data + Direct and Indirect(eg, partnering with CMC , Labeling, etc) execution activities that support Data-based Submissions… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
- Amgen (Thousand Oaks, CA)
- …us and transform the lives of patients while transforming your career. **Global Operations Sr Director , Biosimilars** **What you will do** Let's do this. Let's ... of these programs-accountable for its cross-functional strategy and execution. This Senior Director -level role is enterprise-critical, with high business… more
- Takeda Pharmaceuticals (Lexington, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
- Lilly (Indianapolis, IN)
- …of life saving therapeutics. **Role Overview:** We are seeking a veteran and visionary Sr . Director of Early Phase Chemistry to join our leadership team. This ... lifecycle of an asset ranging from the discovery/development interface through regulatory submission and post-approval changes. We work to improve patient outcomes… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …of bipolar depression in adults as monotherapy and as adjunctive therapy. The Senior Director , Medical Affairs supports the Medical Affairs department in the ... national origin, protected veteran status, disability or any other legally protected status. \#ITCI Sr . Director , Medical Affairs Base Salary range $210K - $270K more
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