- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is ... product in Gilead's global portfolio of biological products in CMC Regulatory Affairs. This position will provide...operate" by maintaining the global licensures. In addition, the Sr Director will be accountable for leading… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... CMC regulatory activities for Lilly/Avid diagnostic radiopharmaceutical products. This includes...effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior … more
- Merck (Rahway, NJ)
- **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director / Senior ... regulatory strategies and provides mentoring and coaching to Sr . Scientist and Assoc Principal scientist in support of...but are not limited to: + Serve as a Regulatory CMC Project Lead and provide … more
- Actalent (Boston, MA)
- Position: Director / Sr . Director of Regulatory CMC Location: Charlestown, MA About the Role We are seeking a creative and agile regulatory ... collaborative team as the Director / Sr . Director of Regulatory CMC . This...self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory...of related experience regulated industry or health authority + Senior Director : 20+ years of related experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule where you ... trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy....CMC team, you will report to the Executive Director and Head, CMC Regulatory … 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:** + ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… more
- Astellas Pharma (Westborough, MA)
- …credibility. **Organizational Context:** Reports to Director or Senior Director , Regulatory Affairs CMC . **Qualifications:** **Required** + BS in ... Pharmaceutical Technology, Quality Assurance, Business Partners). Responsible for developing global CMC regulatory strategy (eg, CMC strategy/planning for… more
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… 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
- Bristol Myers Squibb (Seattle, WA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr . Manager / Associate Director , Global Sterility Assurance CTTO** ... at BMS with our Cell Therapy team. T he ** Sr Manager/Associate Director - Sterility Assurance, Cell...they apply to Cell Therapy . + Experience with regulatory inspections and CMC + Experience with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** **RESPONSIBILITIES** The Sr Director , Analytical ... to operate" throughout the product lifecycle. In addition, the Sr Director will be accountable for leading...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Frontier Medicines (South San Francisco, CA)
- Frontier Medicines is seeking a highly motivated individual for a newly created Director / Senior Director role in Process Chemistry in Frontier's South San ... scale-up challenges + In collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to support all development… 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives on drug-device ... product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC ; international experience is a plus + Experience working… more
- Lilly (Indianapolis, IN)
- …better for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs, Global Regulatory Lead ... development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge of Global… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …life-changing therapies to patients worldwide. **How you will contribute:** + The Senior Director , Pharmaceutical Sciences (PS) Portfolio Leader is accountable ... PS / R&D and the commercial organizations + The Sr . Director , PS Portfolio Leader is a...+ Has knowledge of fundamental understanding in Clinical Sciences, Regulatory CMC , DMPK, Pharmacology and Toxicology +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Integra LifeSciences (Plainsboro, NJ)
- … agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director , CMC Quality Operations. **SUPERVISION EXERCISED** Manages personnel ... system requirements and how they impact product quality and regulatory compliance. + Works with Senior Management...quality and regulatory compliance. + Works with Senior Management to achieve alignment of Quality Goals and… more