Senior Director Regulatory CMC (Retained Search)

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timePosted 9 days ago location United States salarySalary undisclosed
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Job Description

We have partnered with an exciting small biotechnology company located in Emeryville on a retained search for a Sr Director, CMC Regulatory Affairs. This company has been well established for 20 years and currently has a commercialized vaccine on the market treating Hepatitis B. They have a very exciting pipeline including 5 Phase III products, 1 Phase I product, and an additional program that is excluded from public knowledge. They are also working in global partnerships in an effort to create a COVID-19 vaccine. They are currently looking for an experienced Senior Director of Regulatory Affairs CMC who possess a thorough background within the vaccine space. This individual will be responsible for all Regulatory CMC activities including leading interactions with the FDA. This role will be faced with developing and implementing the CMC-relates regulatory strategies for pre-clinical, clinical, and commercial products. Location Emeryville OR Remote Must Have BSBA with 6+ years experience in CMC regulatory affairs Previous management experience with direct reports Deep understanding of FDA regulatory guidelines Experience interfacing and leading meetings with FDA and EU regulators and authorities Strong communication and collaboration skills Preferred Working experience with CDER, CBER, CDRH, andor EU regulators Clinical and commercial supply chain andor labeling regulatory experience Responsibility Partner with department heads, project leaders, and project teams to implement the CMC regulatory strategies Act as the regulatory lead on project teams by providing strategic input and guidance to the project lead on regulatory matters Manage the assembly, review, and approval of regulatory dossiers and documents. Will have the final sign off on CMC regulatory documents. Coordinate US, EU, and global regulatory strategies and provide operational input Serve as the primary point of contact for CMC regulators Manage and interface with CROs and external vendors Sthree US is acting as an Employment Agency in relation to this vacancy.