- Takeda Pharmaceuticals (Lexington, MA)
- …as a Director GRA CMC where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval ... for assigned products as GRA CMC Product Lead . Represents and contributes to Regulatory , Pharmaceutical...across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA… more
- Merck (Boston, MA)
- …Lead quality oversight of product validation, verification, and risk mitigation activities. Regulatory CMC Oversight + Lead the preparation and submission ... pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to senior management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive ... Director and Head, CMC Regulatory Affairs - Pharmaceuticals....in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders… more
- Takeda Pharmaceuticals (Boston, MA)
- …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...Director Global Regulatory Affairs CMC . **How you will contribute:** +... CMC experience including experience as an RA CMC product lead with… more
- Actalent (Boston, MA)
- …Masters, PharmD, or PhD preferred. + Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, ... to Boston area to accommodate flexible hybrid schedule Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member… more
- Sanofi Group (Cambridge, MA)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... management of products. + May serve as a regional/local regulatory lead and point of contact with...pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in… more
- Sanofi Group (Cambridge, MA)
- …for both drug substance and drug product, with strong knowledge of quality, regulatory affairs , and manufacturing and supply. + **Proven ability** to deliver ... pre-clinical, clinical, and commercial phases, including process design, characterization, validation, and regulatory filings. + ** CMC and GMP Knowledge** : Deep… more
- Organon & Co. (Boston, MA)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... in the US** The Director, Translational Medicine and Early Development (TMED) Lead will be responsible for contributing and/or devising the early clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, ... strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that...expected to advance not only the program teams they lead but also other teams that are facing unique… more
- Novo Nordisk (Lexington, MA)
- …Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing ... products within the Novel Modalities team as the medical lead of the ATTR cardiomyopathy project. In doing so,...with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams… more
- Editas Medicine (Cambridge, MA)
- …laboratory scale to production scale + Work with Analytical Method Development, Regulatory Affairs , Quality Control, Quality Assurance, Inventory Control, etc. ... Troubleshoot and problem-solve unresolved or new formula issues + Lead for design and execution of formulation studies supporting...to Clinical Research to DMO to Technical Development to CMC to Regulatory (IND, BLA) through commercialization… more
- Sanofi Group (Cambridge, MA)
- …development experts, statisticians, clinical operations personnel, medical writers, safety experts, regulatory affairs , medical affairs and external key ... is to collaborate with the physicians, assisting GPH, Clinical lead and CRDs in activities around the compound, MA...preparation of supportive documents for AdBoards and meetings with Regulatory Affairs + Literature review update related… more