- FUJIFILM Holdings America Corporation (Boston, MA)
- Overview The Associate Director / Director of Business Development, will be an ambitious salesperson who independently works to identify, qualify, negotiate, and ... events to promote FCDI's CDMO offeringsCoordinate sales calls with C-level and senior leaders at client accounts; prepare and lead presentations and facilitate site… 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 ... 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry, Manufacturing & Controls ( CMC ), the Senior Scientist is ... for the preparation and review of information required for development of regulatory CMC dossiers for products including original registrations, life-cycle… 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
- ThermoFisher Scientific (Wilmington, NC)
- …communities depend on - now and in the future. **Discover Impactful Work:** The Senior Director , Regulatory Affairs Functional Lead, FSP, provides strategic ... in a regulatory affairs function and speciality area (preclinical, clinical, CMC , publishing, etc) + A demonstrated track record of success in leading,… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose** : The purpose of the Sr. Director role in Global Regulatory Affairs (GRA) - Drug Delivery and Digital Health ... by a demonstrated ability to establish and/or to promote / refine key regulatory positions and to effectively influence senior leadership on these positions.… 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
