- Takeda Pharmaceuticals (Boston, MA)
- …activities. Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report ... to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage regulatory submissions for assigned… more
- Sanofi Group (Waltham, MA)
- **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
- Sanofi Group (Cambridge, MA)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800...perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable… more
- Sanofi Group (Framingham, MA)
- …non-viral LNPs), with teams in France, Germany and the USA. Reporting to the head of Global CMC Development, this highly visible role has the potential to make a ... **Job Title:** Global Head, BioAnalytics, CMC Development **Location**...and with other Sanofi functions (eg, Research, Quality Assurance, Regulatory Affairs , Manufacturing & Supply, Business Development).… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement CMC strategies to enable data driven ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
- Sumitomo Pharma (Boston, MA)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Bausch + Lomb (Boston, MA)
- …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA,...Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a… more
- Bausch + Lomb (Boston, MA)
- …strategies across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer… more
- Orchard Therapeutics (Boston, MA)
- …their peers in Europe, the Regulatory CMC team and the VP of Regulatory Science, to ensure a consistent global approach is used for the development and ... discipline preferred. . At least 15 years experience in Regulatory Affairs in the Biotech environment, spanning...technical development of gene or cell-based therapies and associated regulatory CMC activities is not requested. .… 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
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global ), in early ... teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner...and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated… more
- Sanofi Group (Cambridge, MA)
- …with all key stakeholder in GPT and Global Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the ... R&D components of the brand optimization strategy in close collaboration with Market Access, Global Commercial and Medical Affairs , as Active member of GPT. +… more
- Bristol Myers Squibb (Cambridge, MA)
- …lives. Read more: careers.bms.com/working-with-us . **Position Title:** Vice President, Global Program Lead Neuroscience **Position Summary:** The Global ... assets. The GPL role is accountable for leading the Global Program Team and orchestrating the design and execution...with the cross functional GPT members + Participates in regulatory filings (NDA, BLA filings) as well as develops… more
- Takeda Pharmaceuticals (Boston, MA)
- …**:** + Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that ... engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, Pharmacology… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing ... best of my knowledge. **Job Description** **Title: Process Scientist - Global Manufacturing Science GMSci DP/PKG** **Location: Cambridge, MA** **About the role:**… more
- Sanofi Group (Cambridge, MA)
- …their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse ... of products. The team is part of the GRA CMC & GRA Device Department within Global ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Sanofi Group (Cambridge, MA)
- …their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse ... of products. The team is part of the GRA CMC & GRA Device Department within Global ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Sanofi Group (Cambridge, MA)
- …their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse ... of products. The team is part of the GRA CMC & GRA Device Department within Global ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Key Responsibilities** **Process Development & Optimization** + Partner with Regulatory Affairs and cross-functional stakeholders to design, refine, ... a coordinator for controlled document management. + Strong understanding of regulatory submission and registration processes, global health authority… more