Job Description:
Position Summary
This position is a key leadership role for the development of the Zugo-cel CAR-T franchise at CRISPR. Reporting to the Head of Regulatory Affairs, 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.
Minimum Qualifications
- Bachelor’s degree required in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering.
- 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
- Must 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
- A PhD in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering is highly desirable.
- Late phase IND/CTA/GMO submission authoring, and understanding of FDA/EMA requirements for corresponding dossier development
Competencies
- Collaborative 6 Openness, One Team
- Undaunted 6 Fearless, Can-do attitude
- Results Orientation 6 Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit 6 Proactive. Ownership mindset.
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.
Associate Director, Regulatory Affairs CMC: Base pay range of $165,000 to $180,000+ bonus, equity and benefits
The range provided is CRISPR Therapeutics97 reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
