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Director of Regulatory Assurance- (CMC)

Location: N.East
Industry: Pharmaceutical/Biotech
Job Code: 12024-01

Responsibilities:

The CMC Director will lead, maintain, and coordinate all CMC filings and actively supporting all CMC touching filings within the business. Manage timelines in cooperation with project management and plant management. Provide progress updates to senior management. Assist with the scientific writing and review of 1ND, IMPDs, and their amendments and evaluate conformance with the regulatory requirements.

Requirements:

• Degree in a science related discipline and a minimum of ten years of pharmaceutical industry experience. At least 6 years of applicable managerial Regulatory experience in CMC related activities for biologicals, monoclonal antibodies or other large molecule therapeutics. Research laboratory, process development or manufacturing experience with biotechnology products is highly desirable.

•An expert knowledge of 21 CFR Parts 50, 54, 56, 58, 210, 211 312, 314, 600, 601, and 610 and relevant ICH and EMEA guidelines and regulations is required.

•Strong organizational and negotiation skills, excellent written and verbal communication skills and an advanced proficiency in Microsoft Office and desktop publishing applications are necessary. Experience in eCTD production from a users perspective with working knowledge of CoreDossier and QUMAS a strong positive.

Contact:

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