Director, Regulatory CMC Strategy
Posted on Apr 5, 2021 by CRISPR Therapeutics AG
Reporting to the Executive Director of Regulatory Affairs CMC, this is a key role responsible for the strategic development of CMC components of regulatory submissions for assigned projects, both in the US and globally.
In this position, you will drive the development of innovative CMC regulatory strategies as well as the preparation and submission of high-quality CMC sections for INDs, CTAs, BLAs, and MAAs. You will work in close collaboration with CMC teams and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.
CRISPR is a company focused on science, innovation, collaboration and entrepreneurship. This role offers a unique opportunity for a highly motivated individual help bring cutting-edge gene-edited therapies to patients.
Act as Regulatory CMC Lead for assigned programs, providing strategic guidance to cross-functional CMC teams and global regulatory teams
Develop Regulatory CMC strategies for innovative gene-edited drugs where minimal Regulatory precedent is available
Lead and support Health Authority meeting strategy and preparation for CMC topics
Ensure that CMC-related applications, including INDs, CTAs, BLAs, and MAAs are complete, well written, and meet all relevant requirements to achieve timely approval
Build and maintain strong relationships with internal and external stakeholders
Support development of manufacturing, analytical, and supply chain strategies and provide expert regulatory guidance to enable global implementation
Drive adherence to CMC regulatory guidelines relevant for the development of transformative gene-based medicines
Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance, and provide regulatory advice to program teams
Master's degree in biochemistry, chemistry, biology or related pharmaceutical fields
8+ years of relevant biopharmaceutical industry experience and demonstrable track record of accomplishments with at least 5 years of experience in CMC-focused Regulatory Affairs preferably for biologics/vaccines or cell and gene therapies.
Experience with late-stage clinical development, marketing applications, and/or post-approval regulatory dossier life-cycle management required.
Experience supporting internal manufacturing facilities preferred.
Exceptional ability to communicate verbally and in writing, and superb organizational skills required.
Ability to manage multiple priorities within a dynamic organizational and team structure
Current knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products
Working knowledge of eCTD requirements for submission to US and global regulatory agencies for IND, IMPD, BLA, NDA, MAA.