- Merck & Co. (Rahway, NJ)
- …The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS ... CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery...is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial… more
- Merck & Co. (North Wales, PA)
- …The Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide CMC Regulatory ... with risk mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the ... working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define...with DS' strategic objectivesWork with other DS functions (incl. Regulatory - CMC ) to coordinate Regulatory Intelligence… 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 ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional ... Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC , New Products, Sales & Marketing, and ... opening in our Monmouth Junction, NJ facility for a Senior Manager, Business Development.The primary role of the ...input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director, Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Mar 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 ... people to make a difference with. **The opportunity** The Senior Director, Regulatory Affairs CMC is responsible to manage and help develop regulatory… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. ** Senior Advisor/Director, Global Regulatory Affairs - CMC , Small Molecules** At Eli Lilly, we create ... need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Small Molecules will leverage CMC technical knowledge… more
- Lilly (Indianapolis, IN)
- …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the… more
- Merck (Rahway, NJ)
- …The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS ... CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery...is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial… more
- Merck (North Wales, PA)
- …Scientist / Director responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership ... + Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of...Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to… more
- Takeda Pharmaceuticals (Boston, MA)
- …Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs , Pharmaceuticals. **How you will contribute:** ... regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the ... marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs ,...Regulatory Affairs , in collaboration with Head, Regulatory Affairs and CMC -RA, will… more
- Lauridsen Group Inc. (Ankeny, IA)
- The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... to develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs ...ensure alignment with overarching PHB business strategies. + Provide regulatory leadership with expertise in CMC and… more
- CSL Behring (King Of Prussia, PA)
- …business objectives and current health authority expectations. o Provides communications between Global Regulatory Affairs CMC and partners within GRA and ... you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located...Health Authorities, Industry Associations) and company partners to shape regulatory CMC requirements. You will lead and… more
- ThermoFisher Scientific (High Point, NC)
- …the FDA. Additionally, this position requires representation and advisory support to the Regulatory Affairs (RA) team in R&D project teams, providing expertise ... Point, NC site. This role involves writing and reviewing CMC documents in compliance with pharmaceutical regulatory ...Assessment of RA changes and change controls + Represent Regulatory Affairs in project teams + Pharmacovigilance… more
- Bausch + Lomb (Bridgewater, NJ)
- …the advancement of eye health in the future. **Objectives/Purpose of Job:** + The Regulatory Affairs Senior Specialist handles US regulatory development ... Regulatory Authorities for assigned products. + Liaise with country-specific regulatory affairs personnel for international submissions and registrations. +… more
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs ? This position is located ... regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC...GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide… more
- Ascendis Pharma (Palo Alto, CA)
- …activities and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a ... in Palo Alto, CA and reports directly to the Senior Director, Regulatory Affairs . Key.... Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC… more
- Ascendis Pharma (Palo Alto, CA)
- …activities and those of direct reports . Work is performed under direction of a Senior Regulatory Affairs professional Contribute to internal regulatory ... The Director, Regulatory Affairs will be responsible for... will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC … more
