- Takeda Pharmaceuticals (Lexington, MA)
- …+ Successfully communicate and negotiate with international Health Authorities, representing Takeda Global Regulatory Affairs CMC in meetings ... is possible in order to bring life-changing therapies to patients worldwide. The Director CMC Regulatory Affairs is responsible for ensuring regulatory … more
- Takeda Pharmaceuticals (Lexington, MA)
- …years) required. + Highly proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global ... + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for...CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to… 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 ... **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director) **Location** : Cambridge, MA or… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …+ Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC ) for investigational and commercial products ... leadership and oversight to the development of innovative regulatory affairs and CMC ...Responsible for the strategic company guidance on FDA and global regulatory CMC requirements for… more
- Sanofi Group (Framingham, 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
- Chiesi (Boston, MA)
- …Who we are looking for Purpose Currently seeking for a Regulatory Affairs Specialist to support preparation of CMC related submissions and assessment of ... Affairs specifically with Small Molecules focused on Regulatory CMC + Good understanding of the...drug development and life-cycle management process + Familiarity with global CMC regulations, including ICH requirements and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …and response to regulatory health authorities. + Leads the development of global CMC regulatory science-based strategies for internal RCM oncology ... Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be...Quality teams, contract manufacturing organizations, external experts, collaborators, and global health authorities. **In this role, a typical day… more
- Fresenius Medical Center (Waltham, MA)
- …+ 12+ years of experience in regulatory affairs , focusing on regulatory strategy, submissions, and global market access in the pharmaceutical industry. + ... clinical/medical, CMC , and post-market phases. + Monitor regulatory trends, updates, and guidance from global ...a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred.… 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
- Fresenius Medical Center (Waltham, MA)
- …meet formatting, technical, and regulatory standards. + Collaborates cross-functionally with Regulatory Affairs , CMC , Medical Writing, Quality, and other ... in the pharmaceutical or biotechnology industry, with a strong emphasis on global regulatory submissions. + Proven expertise in the preparation, compilation,… more
- Fresenius Medical Center (Waltham, MA)
- … requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support global creation and ... maintenance of regulatory documentation + Management of global teams within change projects + Expert and interface...project management respectively change control process + Experience in regulatory affairs or in a quality environment,… more
- Sanofi Group (Framingham, MA)
- …with CMC , R&D Vaccines, Global Quality, Alliance Management, Global Regulatory Affairs , Clinical Supply Operations, Business Development, Legal, ... and across all responsible sites We are an innovative global healthcare company with one purpose: to chase the...to the head of GMU operations. + Participate in regulatory inspections at the CMOs and CTLs in scope.… more
- Bristol Myers Squibb (Devens, MA)
- …Management, site and above site QA and QC, Internal and External Manufacturing, Regulatory Affairs and Brand teams. The individual provides end-to-end global ... resources to serve as single points of contact for product-related changes, and Regulatory CMC liaisons responsible for coordinating reviews of regulatory … more
- Takeda Pharmaceuticals (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum… more
- Rhythm Pharmaceuticals (Boston, MA)
- …stakeholders, including CMC Drug Substance, Supply Chain Management, Quality, and Regulatory Affairs . + Manages and executes activities related to drug ... will collaborate with partners in Supply Chain, Quality Assurance, Regulatory Affairs , Finance and various CRO/CMO's to...as required. + Authors and reviews relevant drug product CMC sections for global regulatory … more
- Organon & Co. (Boston, MA)
- …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
- AbbVie (Cambridge, MA)
- …of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls ( CMC )). + Experience with ... part of the Corporate Strategy Office and actively supports global Business Development (BD) goals by sourcing and assessing...acquire assets. The group is responsible for leading the global search efforts for assets of high strategic value… more