- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing ... INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC ...NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and… more
- Formation Bio (New York, NY)
- …where you will work closely with our business development, legal, clinical, CMC , and data/engineering teams to on-board products with strong IP potential, and ... thereafter coordinate patent and regulatory activities to deliver best-in-class IP positions. We expect this person to create and influence strategy, assist with… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... commercial strategy.Collaborate closely with internal functions such as Pharmacology, CMC , Regulatory Affairs, Clinical, and Program Management.Maintain… more
- Organon & Co. (Plymouth Meeting, PA)
- …Safety Assessment Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of strategy across the ... Additionally, cross-functional interactions with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls… more
- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (eg, CMC strategy/planning for… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. 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...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …and Controlslead for Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA and other Health ... **Overview** The Director , CMC provides leadership for the...of regulatory submissions. + Experience with complex CMC regulatory submissions for both development and… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Job Summary** The Director / Senior Director , CMC , Drug Product Development will lead ... capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… more
- Sumitomo Pharma (Lincoln, NE)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a key ... Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area. + Acts… 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) ... experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area neuroscience and/or immunology… more
- ThermoFisher Scientific (Greenville, NC)
- …all while maintaining full-time benefits. **Position Summary** The Director , Clinical Regulatory Affairs serves as a senior regulatory leader responsible ... RFIs to support timely trial startup and advancement. The Director , Clinical Regulatory Affairs partners closely with...programs, territories, and development milestones. + Serve as the senior regulatory advisor to program teams, helping… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. Regulatory Policy and Intelligence - US Director **Live** **What you will do** Let's ... stakeholders (eg, Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory policy perspective + Assists and advises senior leadership in… more
- Takeda Pharmaceuticals (Boston, MA)
- …roles, with deep expertise across Pharmaceutical Sciences + Strong understanding of CMC processes, GxP, regulatory compliance and global quality standards + ... & Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- **Job Summary** The Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head, reporting to the VP, Translational Medicine and Early ... Clinical Development within OPDC's Early Development Organization (EDO). The Senior Director Translational Medicine will oversee a small team of CNS… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director ,** **Product Management** **Team** **Lead** **(Early Phase)** ... operating within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director , Product Management Team Lead** will lead a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Global Supplier Quality** Gilead Sciences, Inc. is a ... External Quality is currently seeking a leader at the Senior Director level to lead a team...Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC , and the Gilead Site Quality… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Site Quality Head, Goa...technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions, + Deep ... and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products. This oversight includes but is not… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director , Global Program Leader - Oncology, Solid Tumors in our Cambridge office. ... experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability… more
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