ASSOCIATE DIRECTOR REGULATORY CMC jobs in BOSTON MA, United Kingdom

Job Description General Summary: The Associate Director, Regulatory CMC executes multi-product global regulatory... and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role...

One of AL Solutions leading biotech client's is looking for an Associate Director of Analytical Development CMC. In..., release testing, and stability studies Overseeing method validation activities and ensuring compliance with regulatory...

: As an Associate Director in Analytical Development, it is expected that the individual will independently lead efforts in development... Analytical Quality by Design (AQbD) Experience in reviewing and approving analytical-related CMC sections of BLA/MAA regulatory...

Job Description As a key team leader in the Manufacturing Sciences & Technology function, the Associate Director... procedures Knowledge and Skills: Knowledge of cGMP’s (e.g. Quality Control), ICH guidelines, and associated CMC regulatory...

Job Description The Associate Director, Manufacturing Science and Technology (MSAT) – Materials Science will support.... Experience with cGMP regulations/guidance and regulatory agency inspections. Experience authoring/reviewing CMC product...

site(s). · Partner with key stakeholders and work collaboratively with cross-functional CMC, quality, regulatory, project.... Regulatory filing experience with IND preferably with BLA too. Experience submitting authoring CMC sections for single fill...

Be well versed in all stages of pharmaceutical development and understands the global regulatory trends for CMC activities, to ensure... CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all local project-related...

, finished goods packaging/labeling and quality and regulatory operations necessary to deliver IMP to patients. The CSL will work... as a member of the cross-functional CMC Team to understand upcoming clinical trials and build out study plans and timelines...

documentation, CMC sections of regulatory documents, or validation plans and reports within expertise for review. As part of the... Analytical Development team, you will report to Associate Director, Analytical Development. How you will contribute: Develop...

metrics. As part of the Synthetic Molecule Process Development (SMPD), you will report to Associate Director, Process... or influencing others in a matrix environment. Prepare and coordinate the completion of technical documentation, regulatory...