Crispr Therapeutics Inc
Associate Director/Director, Regulatory CMC
Crispr Therapeutics Inc, Boston, Massachusetts, us, 02298
Job Description
Position
Regulatory CMC Lead, In Vivo Franchise (Biologics/Gene Therapy)
Company Overview
CRISPR Therapeutics has transformed from a research-stage company to a portfolio of product candidates across disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The company partners with leading organizations and operates with a U.S. subsidiary and R&D in Boston, MA and San Francisco, CA.
Position 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 devise and implement innovative Regulatory strategies where little precedent exists, and collaborate with CMC and global development teams, external partners, and health authorities.
Responsibilities
Act as Regulatory CMC Lead for assigned programs, providing strategic guidance to development teams on complex Regulatory CMC topics.
In 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 for global implementation.
Drive adherence to CMC regulatory guidelines relevant for the development of transformative gene-based medicines.
Participate in regulatory intelligence activities related 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 with a bachelor’s; 10+ years with an advanced degree.
Director: 15+ years with a bachelor’s; 12+ years 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 ability to apply these principles to Regulatory CMC strategies for novel products.
Working knowledge of eCTD requirements for submissions to US and non-US regulators (IND, IMPD, CTA, BLA, NDA, MAA).
Exceptional verbal and written communication skills and superb organizational abilities.
Ability to manage multiple priorities within a dynamic organizational structure.
Preferred Qualifications
PhD in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering is highly desirable.
Regulatory Affairs CMC experience with mRNA/LNP is a plus.
Competencies
Collaborative – Open to teamwork and one-team mindset.
Undaunted – Fearless, can-do attitude.
Results oriented – Delivers progress toward the mission with urgency.
Entrepreneurial spirit – Proactive ownership mindset.
CRISPR Therapeutics fosters a dynamic workplace with remote work flexibility and on-site collaboration. Some lab-based and manufacturing roles are fully on-site.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please refer to our privacy policy.
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Regulatory CMC Lead, In Vivo Franchise (Biologics/Gene Therapy)
Company Overview
CRISPR Therapeutics has transformed from a research-stage company to a portfolio of product candidates across disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The company partners with leading organizations and operates with a U.S. subsidiary and R&D in Boston, MA and San Francisco, CA.
Position 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 devise and implement innovative Regulatory strategies where little precedent exists, and collaborate with CMC and global development teams, external partners, and health authorities.
Responsibilities
Act as Regulatory CMC Lead for assigned programs, providing strategic guidance to development teams on complex Regulatory CMC topics.
In 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 for global implementation.
Drive adherence to CMC regulatory guidelines relevant for the development of transformative gene-based medicines.
Participate in regulatory intelligence activities related 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 with a bachelor’s; 10+ years with an advanced degree.
Director: 15+ years with a bachelor’s; 12+ years 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 ability to apply these principles to Regulatory CMC strategies for novel products.
Working knowledge of eCTD requirements for submissions to US and non-US regulators (IND, IMPD, CTA, BLA, NDA, MAA).
Exceptional verbal and written communication skills and superb organizational abilities.
Ability to manage multiple priorities within a dynamic organizational structure.
Preferred Qualifications
PhD in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering is highly desirable.
Regulatory Affairs CMC experience with mRNA/LNP is a plus.
Competencies
Collaborative – Open to teamwork and one-team mindset.
Undaunted – Fearless, can-do attitude.
Results oriented – Delivers progress toward the mission with urgency.
Entrepreneurial spirit – Proactive ownership mindset.
CRISPR Therapeutics fosters a dynamic workplace with remote work flexibility and on-site collaboration. Some lab-based and manufacturing roles are fully on-site.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please refer to our privacy policy.
#J-18808-Ljbffr