- Takeda Pharmaceuticals (Boston, 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
- 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
- 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. (Providence, RI)
- …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
- Merck (Providence, RI)
- …position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility ... system aspects are integrated + Stay abreast of evolving global regulatory landscapes for medical device and...Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , … 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)
- …Stage I Validation: Partner with managers and team leaders within DS and Analytical, CMC Development, and Regulatory Affairs to influence Sanofi practices ... on development of second-generation DS processes and associated control strategies, global regulatory submissions, and variation management for biologics drug… 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
- 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