Scientific - Global Regulatory CMC Manager

2 months ago


Akron, Ohio, United States Net2Source Inc Full time

We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.Responsible for the global regulatory evaluation of CMC change controls with supervision.Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)Experience in developing CMC regulatory strategy



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