Regulatory CMC Lead, Gene Therapy — Global Submissions

Solid Biosciences; Boston (MA); Hybrid; USD 170,000 - 220,000; Full time

Benefits offered by this job

Competitive health and dental programs

401(k) with company match

Paid tuition reimbursement

Onsite gym

Daily subsidized lunch

Employee stock purchase plan

Job summary

A genetic medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication skills, and the ability to work collaboratively across teams. The ideal candidate will handle CMC content for clinical trials and engage with agency interactions. The role offers competitive compensation between $170,000 and $220,000 along with extensive benefits.

Qualifications

• Minimum of 4 years of experience in regulatory affairs in the pharmaceutical/biotech.
• Knowledge of recombinant manufacturing processes required.
• Strong knowledge of US and EU regulations pertaining to biological product development.

Responsibilities

• Lead CMC content for global clinical trial applications.
• Collaborate with cross-functional teams to refine product development strategy.
• Drive and contribute to regulatory CMC content and submissions.

Skills

Regulatory affairs experience

Communication skills

Organizational skills

Collaborative teamwork

Problem-solving abilities

Education

Bachelor’s degree in a scientific discipline

Masters, PharmD, or PhD preferred

Job description

A genetic medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication skills, and the ability to work collaboratively across teams. The ideal candidate will handle CMC content for clinical trials and engage with agency interactions. The role offers competitive compensation between $170,000 and $220,000 along with extensive benefits.