- 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
- BeiGene (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 (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) ... 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director in Biologics Analytical Development (Pivotal and Commercial)** ... **Foster City, CA** The ** Senior Director in Biologics Analytical Development (Pivotal...Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical… more
- AbbVie (North Chicago, IL)
- …delivering diligence project objectives. + Stay abreast of developments in global CMC technical, regulatory and compliance arena and industry practice ensuring ... is responsible for representing Development Sciences Chemistry Manufacturing & Controls ( CMC ) space to Corporate Licensing and Acquisitions (L&A) in the evaluation… more
- AbbVie (Boston, MA)
- …and Controls ( CMC ) dossier strategy and authoring to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. Responsibilities ... influencing the generation of data packages that support the CMC control strategy. The Director II oversees...strategy to health authorities, contributes to the preparation of regulatory query responses and briefing books, and serves as… more
- Sumitomo Pharma (Marlborough, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Director , Business Development.** The Senior Director , ... for review of definitive agreement sections + Work with R&D, Finance, IP, legal, CMC , corporate communications, commercial and others + Work with ED of BD on… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director , PDM Product Strategy Leader** **Foster City, CA** **KEY ... in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory , or process development, or as part of a cross-functional… more
- AbbVie (North Chicago, IL)
- …functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Authors scientific publications and present ... Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director , Global Program Leader (GPL) in our Cambridge office. At Takeda, we ... experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability… more
- Vera Therapeutics (Brisbane, CA)
- …suffering from immunological diseases. Position Summary: The Senior Manager, Clinical Regulatory will report to the Director , Clinical Regulatory and ... Title: Senior Manager, Clinical Regulatory Location: Brisbane,...The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * Proactively… more
- Rhythm Pharmaceuticals (Boston, MA)
- …in Tech Ops (eg, API Lead, DP Lead, Analytical, Quality, Supply Chain) and Regulatory CMC + Understand and track key activities for delivering drug substances, ... together. Opportunity Overview Rhythm is seeking an experienced and highly motivated Director , Program Management to join its Program Management team, reporting to… more
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