- Actalent (Boston, MA)
- …regulatory professional eager to join a collaborative team as a Director / Sr . Director of Regulatory CMC based in Boston with a hybrid option. This ... Job Title: Director Regulatory CMC Job Description We are seeking a creative and agile … more
- Bristol Myers Squibb (Indianapolis, IN)
- …in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing...care resources. Other perks like tuition reimbursement and a recognition program. If you come across a role that… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC technical ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …of experience in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. + ... **1. Strategy and Roadmap Development** + Define and continuously refine a CMC RA Digital Enablement roadmap aligned to organizational priorities and enterprise… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides advice and ... with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... bring life-changing therapies to patients worldwide. Join Takeda as an Senior Manager, Global Regulatory Affairs, CMC Small Molecules where you will oversee… more
- Boehringer Ingelheim (Ridgefield, CT)
- …is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... the project(s), in support of CMC development within EACD. The Associate Director / Senior Associate Director of EACD for drug product develops… more
- AbbVie (North Chicago, IL)
- …issues is required. Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Pharma Product Group Associate Director will be fully accountable for providing CMC leadership and… more
- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution of multiple ... Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority… more
- Merck (North Wales, PA)
- …products that improve human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization supports Development and Commercialization ... Teams (DCTs) responsible for building and executing CMC development plans. Under the guidance of the CIPM...Manager & Portfolio Lead, the core responsibility of this senior Project Manager (PM) role will be to manage… 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
- 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
- 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
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... of drug candidates to support clinical trials, product commercialization, and regulatory submissions. The position presents an opportunity to lead dynamic teams… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Join Kite and help create more tomorrows. **Job Description** We are looking for a Sr Director , Analytical Operations to join our team at our Kite headquarters ... the highest industry standard + Draft and review of CMC sections and supporting documents for Regulatory ...ability to work with both subordinate staff and corporate senior leadership team + Excellent interpersonal, verbal and written… more
- ThermoFisher Scientific (Greenville, NC)
- …Experience** **(You MUST show the above in your submittal to be considered)** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher Scientific, you'll ... general medicine and vaccines. **Discover Impactful Work:** We are seeking a ** Senior Director , Project Management** in our **Non-Interventional Oversight Team… more
- Bristol Myers Squibb (Summit, NJ)
- …support and leadership within the Global Product Quality organization . The Sr . Director a uthor s designated sections of regulatory filing s , review s ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director , Cell Therapy Global Product Quality...queries, as needed . + R epresent Quality in CMC meetings with global regulatory agencies and… more