Manager, Regulatory Affairs - CMC Who we are: is a biopharmaceutical company that is fueled by connections... you will make: Agios Pharmaceuticals is searching for a dynamic Manager of Regulatory Affairs - CMC to join our Regulatory Affairs...
to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects.... Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up...
Project Coordinator - Regulatory CMC - Contract - Cambridge, MA (hybrid role) Proclinical is seeking a Project... Coordinator to join the Regulatory Affairs - CMC Team. Primary Responsibilities: The successful candidate will provide high...
Job Title: Intern - Regulatory Affairs, CMC (year-round) Job Location: United States Job Location Type: Remote.... Requirements The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely...
Job Description The QA Associate Director, CMC Regulatory Submission QC and Audit, is responsible for the audit.../review of all regulatory submissions in support of submission readiness for small molecule, biologics, and medical devices...
of multi-product global regulatory CMC strategies for investigational and marketed products. This role is accountable for the... preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics...
. We are looking for a dynamic and experienced Senior Manager, Project Management in Chemistry, Manufacturing, and Controls (CMC) to join our growing... expertise in CMC project management, strong leadership skills, and a solid understanding of regulatory requirements in the...
, site QA/QC, and regulatory CMC) and commercial functions (i.e., AS&T, MS&T, QC, QA Operations, Supply Chain) to enable..., etc.) are used. Support preparation of CMC clinical and commercial regulatory submissions by critically reviewing and approving...
." Who we are looking for Purpose Currently seeking for a Regulatory Affairs (RA) Manager with strong CMC pre and post... functional teams in obtaining the necessary CMC documentation in support of a regulatory submission. Assist in the development...
Job Description General position summary: The Director CMC Compliance provides strategic leadership and quality... oversight of the GMP/GDP Regulatory Intelligence and Surveillance space for small molecule, biologics and devices/combo devices...
JOB TITLE: Manager/Senior Manager Biologics Drug Product DEPARTMENT: Technical Operations/Biologics CMC REPORTS...: The Manager or Senior Manager Biologics Drug Product will be responsible for all aspects of drug product process...
Industry: Pharmaceuticals Title: Quality Assurance Operations Manager Job ID: 2025-8807 Location: Cambridge... onsite preferred but open to remote (can sit anywhere in US). Remote workers will work EST time zone. Overview The Manager...
with cross-functional teams to integrate nonclinical, clinical, regulatory, and CMC activities across all stages of development...R&D PROJECT MANAGER Incendia Therapeutics is a precision oncology company dedicated to reprogramming the tumor...
, through registration, clinical trials, and commercial launch Advanced knowledge of cGMPs and associated CMC regulatory...Job Description General Summary: The Package Engineering Senior Manager is an emerging professional within the...
to join our growing CMC team. As a Clinical Supply Manager, you will be responsible for managing the clinical supply chain for clinical... with internal stakeholders (clinical operations, regulatory affairs, quality, CMC, etc.) to ensure seamless coordination...
Job Description General Summary: The Clinical Supply Chain Manager is responsible for forecasting, packaging... as primary point of contact with contract manufacturing partners Forecasting supply needs in conjunction with Clinical and CMC...
with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory CMC, and Analytical Development, to ensure... process in accordance with regulatory standard. This role reports to the Director of Quality Control in Cell and Genetic...
departments May draft process descriptions for the CMC section of regulatory documents for early development projects A track... and technical leadership Familiar with early and late phase pharmaceutical development and regulatory expectations Work with Pharm...
for supporting global launches of new products and driving efficiencies throughout the product lifecycle Supports Regulatory on CMC... manufacturing, regulatory, device manufacturing, pharmaceutical sciences, clinical/commercial supply chain, logistics...
to evaluate investment opportunities, and manage business and regulatory risks to ensure company’s investments align.... Collaborate with R&D Finance, CMC/Manufacturing Finance and Program Management teams to maintain accurate and up-to-date R...