Regulatory Affairs CMC, Associate Director
|Job Title:||Regulatory Affairs CMC, Associate Director|
|Contact Name:||Gerry Kennedy|
|Job Published:||about 3 years ago|
Our client is a young exciting multinational biopharmaceutical company known for its scientific and operational excellence enjoying exceptional growth combined with a strong high potential pipeline. Rapid expansion has led to the need to create a management position in Regulatory Affairs CMC to be based in their Dublin office
Maintain active engagement with emerging and current regulatory trends in the industry and act in a consultative capacity to our Industrial Operations and Product Supply and clinical regulatory affairs as related decisions and processes are executed. Support all CMC regulatory filing activities for various pre-INDs, INDs, IMPDs, CTAs and BLAslMAAs and track regulatory commitments
? Manage timelines in cooperation with project management, Operations, SMEs and Regulatory Operations (RegOps) to ensure on time regulatory submissions.
? Assist with the planning, scientific writing and perform critical reviews of preINDs, INDs, IMPDs. BLAs, MAAs, annual reports, DSUR, amendments, supplements to ensure a high quality regulatory submission and approval
? Ensure that all regulatory submissions are of highest regulatory standards.
? Coordinate and manage regulatory inspections, as needed if the inspection relates to regulatory CMC issues.
? Assist in review of manufacturing change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAslMAAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements.
? Support establishing, managing and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.
? Assist in tracking of CMC regulatory commitments for INDsIIMPDs, CTAs, and BLAslMAAs.
? Participate, as needed, in planning, organizing and managing the CMC component of pre-IND and pre"BLA meetings with FDA
? Support Ops by providing CMC related guidances so that their short-term and long-term goals are achieved on time and with highest quality.
? Participate in CMC project team meetings and provide current regulatory requirements that pertain to stability studies and analytical characterization tests.
Person Spec :
Requires a Ph.D. or M.S. degree in a science related discipline and a minimum of 10 years pharmaceutical industry experience and 6 years of relevant CMC biotech/pharmaceutical industry experience.
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