Associate Director, Regulatory Affairs CMC

Crispr Therapeutics Inc in; Boston (MA); Hybrid; USD 165,000 - 180,000; Full time

Job summary

CRISPR Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based medicines.

You will collaborate with cross-functional teams and partners to devise innovative regulatory strategies while coordinating with contract manufacturers and health authorities worldwide. Reporting to the Head of Regulatory Affairs, you will manage complex CMC topics, prepare high-quality submissions, and guide global teams through INDs, CTAs,

Qualifications

• Bachelor's degree in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering.
• 12+ Years of relevant experience with a bachelor's degree; 10+ Years with an advanced degree (Associate Director).
• Direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies with accomplishments (e.g. IND).
• FDA, EMA and ICH regulations knowledge and application to CMC strategies for novel products.
• Working knowledge of eCTD requirements for US and ex-US submissions (IND, IMPD, CTA, BLA, NDA, MAA).
• Exceptional verbal/written communication and superb organizational skills.
• Ability to manage multiple priorities in a dynamic environment.

Responsibilities

• Act as Regulatory CMC Lead for assigned programs and provide strategic guidance on CMC topics.
• 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 regulatory guidance for global implementation.
• Drive adherence to CMC regulatory guidelines for gene-based medicines.
• Participate in regulatory intelligence related to global CMC regulations and guidance.
• Build and maintain relationships with internal and external stakeholders.

Skills

Regulatory leadership

Communication

Organization

Cross-functional collaboration

Multi-tasking

Education

Bachelor's degree in biochemistry/chemistry/biology or related field

PhD desirable

Tools

eCTD knowledge

IND/CTA submissions

Job description

Associate Director, Regulatory Affairs CMC (Project Management)

Job Description

Company Overview

Founded over a decade ago,CRISPR Therapeuticsis a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY ® (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia.CRISPR Therapeuticsis advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact,CRISPR Therapeuticshas established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals .CRISPR Therapeutics AGis headquartered inZug, Switzerland , with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based inBoston, MassachusettsandSan Francisco, California .

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
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.

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 Therapeutics' 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.

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.