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Associate Director/Director, Regulatory CMC
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This position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Head of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to devise and implement innovative Regulatory strategies where little precedent exists. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities. Responsibilities Minimum Qualifications - Prior regulatory CMC experience with a demonstrated track record of significant accomplishments :
Associate Director : + 12+ Years of relevant experience with a bachelor's degree + 10+ Years of relevant experience with an advanced degree
Director : + 15+ Years of relevant experience with a bachelor's degree + 12+ Years of relevant experience with an advanced degreeMust have direct experience in Regulatory Affairs CMC for biologics / vaccines or cell and gene therapies, with a demonstrated track record of significant accomplishments (e.g. successful IND, leading health authority interactions on CMC topics).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 ex-US regulatory agencies for IND, IMPD, CTA, BLA, NDA, MAA. 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. Preferred Qualifications Regulatory Affairs CMC experience with mRNA / LNP Competencies
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
