Associate Director/Director, Regulatory CMC

Role Summary

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

• Act as Regulatory CMC Lead for assigned programs providing strategic guidance to development teams on complex Regulatory CMC topics.
• In close collaboration with the CMC team, plan, prepare, and submit high-quality CMC related applications including INDs and CTAs globally.
• Communicate with regulatory agencies on CMC topics, as appropriate.
• Lead and support Health Authority meeting strategy and preparation for CMC topics.
• Assess proposed technical changes and provide strategic 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.
• Build and maintain strong relationships with internal and external stakeholders.

Qualifications

• Required: Bachelor’s degree in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering.
• Required: 12+ years of relevant experience with a bachelor's degree; 10+ years of relevant experience with an advanced degree for Associate Director level.
• Director: 15+ years of relevant experience with a bachelor's degree; 12+ years of relevant experience with an advanced degree; must have direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies, with a 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 verbal and written communication, and superb organizational skills.
• Ability to manage multiple priorities within a dynamic organizational and team structure.
• Preferred: PhD in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering is highly desirable.
• Preferred: Regulatory Affairs CMC experience with mRNA/LNP.

Skills

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.