- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Mar 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 ... new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage 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 ... regulatory strategies and provides mentoring and coaching to Sr . Scientist and Assoc Principle scientist in support of...but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide … more
- Merck (Rahway, NJ)
- …to peptides, pediatric formulations, and devices. The Executive Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, ... and expanding your career. The Chemistry, Manufacturing & Controls ( CMC ) Pre-approval Pharm Executive Director is accountable... CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery… more
- Takeda Pharmaceuticals (Boston, MA)
- …GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you ... regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… 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
- Frontier Medicines (Boston, MA)
- 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)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... within overall CMC development project(s), to support Sr CMC Lead. In case no ...- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose** : The purpose of the Sr . Director role in Global Regulatory Affairs (GRA) - Drug Delivery and ... by a demonstrated ability to establish and/or to promote / refine key regulatory positions and to effectively influence senior leadership on these positions.… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Sr . Director , Statistical Programming provides technical leadership to portfolio ... delivery and building / retaining highly skilled talent in Statistical Programming. Sr . Director , Stats Programming, proactively creates and implements delivery… more
- Gilead Sciences, Inc. (Foster City, CA)
- …headquarters 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
- Lilly (Cambridge, MA)
- …significant improvements in healthy outcomes for our customers. We are seeking an Executive/ Senior Director - DDCS Drug Delivery and New Product Innovation to ... the Medicines Innovation Hub and the Business Units, as well as leaders in Regulatory and Manufacturing to define and deliver our strategy. This individual will be… 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
- Editas Medicine (Cambridge, MA)
- …and distribution of non-GMP materials at all locations. Key Responsibilities: As the Sr . Director , Supply Chain, you will be responsible for: + Building ... and Technical Operations and partner with leadership in TechOps, ClinOps, Finance, CMC and Program Teams to lead short-term integrated production and raw materials… 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
- 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
- Sanofi Group (Bridgewater, NJ)
- …CMC / GRA-Devices. Attends HA meetings and collaborates with the regions / GRA- CMC /GRA-Devices to communicate the outcome to senior management as needed + ... team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages...a later diagnosis. **Main responsibilities:** + Leads the US regulatory post-marketing activities. + As a key member of… more