- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs , CMC will be responsible for reviewing the CMC ... regulatory strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation in coordination with… more
- Insmed Incorporated (NJ)
- …in agency interactions and product development meetings.Understanding of scientific principles and regulatory CMC requirements relevant to global drug ... Role:This position is a key role that will provide regulatory CMC (RA CMC ) leadership...of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast… more
- Parexel (Columbia, SC)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios - Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness - Participate in monthly CMC Global Regulatory Team meetings… more
- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the ... INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC ...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Insmed Incorporated (San Diego, CA)
- … Affairs and relevant teamsWith oversight from the VP of Regulatory Affairs , lead the development and implementation of global regulatory strategy ... of science, we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the ...identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …and commercial strategy.Collaborate closely with internal functions such as Pharmacology, CMC , Regulatory Affairs , Clinical, and Program Management.Maintain ... Legend Biotech is a global biotechnology company dedicated to treating, and one...research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our… more
- Organon & Co. (Plymouth Meeting, PA)
- …+ Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification?of? ... **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing… more
- Insmed Incorporated (NJ)
- …QC content for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC ... or practices from external labs.Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs , Supply Chain, and other departments to ensure… more
- Parexel (Tallahassee, FL)
- …Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and ... Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role,...role, you will be responsible for developing and executing global regulatory strategies for our clients' marketed… more
- Organon & Co. (Plymouth Meeting, PA)
- … product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more
- BeOne Medicines (Emeryville, CA)
- …role provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs , Quality, Safety/Pharmacovigilance, Clinical, CMC , and ... analytics, and continuous improvement initiatives, helping to strengthen BeOne's global regulatory compliance framework and ensuring proactive identification… more
- CSL Behring (Waltham, MA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ... SMT and related delivery teams. May lead discussion at Global Regulatory Forum (GRF) or with senior...maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . -Applies the CSL Leadership Capabilities… more
- Organon & Co. (Plymouth Meeting, PA)
- …development programs with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, Manufacturing ... and Controls ( CMC ), medical affairs and business development. Non-Clinical Safety Assessment Representative is...books, or other regulatory communications for regional regulatory submissions or renewals for global products… more
- Organon & Co. (Jersey City, NJ)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans....live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA/ Waltham, MA/ Morristown, NJ **About the Job** Are you ready to shape the ... we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as a… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical ... molecules and/or synthetic peptides, proteins or oligonucleotide. + Knowledge of global CMC regulatory requirements and guidelines for reporting post… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... products CMC science and manufacturing processes. + Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes… more
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... synthetic molecule CMC drug development science(s). + Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** The Global Regulatory Affairs , Chemistry, Manufacturing, and Controls (GRA CMC ) team resides within Takeda's ... complex regulatory environment, we partner to develop and execute innovative CMC regulatory strategies to provide high-quality medicines and technologies to… more
