Regulatory Affairs CMC Lead – Gene Therapy (Hybrid)

CRISPR Therapeutics; Boston (MA); Hybrid; USD 165,000 - 180,000; Full time

Benefits offered by this job

Bonus

Equity

Comprehensive benefits

Job summary

CRISPR Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive experience in CMC regulatory requirements for biologics and gene therapies.

The ideal candidate will have over 12 years of regulatory experience and a strong understanding of FDA and EMA guidelines, with a proven record of successful submissions. This position promotes a collaborative work environment with flexible remote options.

Qualifications

• 12+ years in regulatory CMC with bachelor’s or 10+ years with advanced degree.
• Direct experience in CMC for biologics/vaccines or cell and gene therapies.
• Knowledge of FDA, EMA, and ICH regulations.

Responsibilities

• Lead CMC strategy for assigned programs.
• Prepare and submit CMC applications.
• Communicate with regulatory agencies.

Skills

CMC regulatory knowledge

Collaboration

Regulatory strategy development

Communication skills

Organizational skills

Education

Bachelor’s degree in biochemistry, chemistry, biology, or related fields

PhD in relevant field (preferred)

Job description

CRISPR Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive experience in CMC regulatory requirements for biologics and gene therapies.

The ideal candidate will have over 12 years of regulatory experience and a strong understanding of FDA and EMA guidelines, with a proven record of successful submissions. This position promotes a collaborative work environment with flexible remote options.