- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing and ... their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as...responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide … 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 ... development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- Insmed Incorporated (Bridgewater, NJ)
- …DABT/DACVP certification preferred. Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewOverview The Director , Toxicology, is a key member of the nonclinical safety team,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the short ... is compatible with DS' strategic objectivesWork with other DS functions (incl. Regulatory - CMC ) to coordinate Regulatory Intelligence activities and ensure… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and help develop … more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. ** Senior Advisor/ Director , Global Regulatory Affairs - CMC , Small Molecules** At Eli ... medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage … more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... their assigned projects. **Position Description** **The Principal Scientist / Director responsibilities include but are not limited to:** +...but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide … 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES ... The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… 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 (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA Pharmaceuticals- Small Molecule where...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the short ... with DS' strategic objectives + Work with other DS functions (incl. Regulatory - CMC ) to coordinate Regulatory Intelligence activities and ensure regulatory… 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,...Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and… 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
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports . Work is performed under direction of a Senior Regulatory Affairs professional Contribute to internal regulatory policies and ... The Director , Regulatory Affairs will be responsible...Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC … more
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager, Global Regulatory Strategy, US & Canada, AbbVie Inc., ... within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director , or ...response to Health Authorities during application review. . Support CMC sections of major, complex regulatory submissions,… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... functional leadership (including but not limited to clinical Operation, Quality, Regulatory , CMC , and GRDS) to ensure alignment of organizations and prompt… more
