Senior Director, Regulatory CMC Strategy & Submissions

Beam Therapeutics; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Beam Therapeutics is seeking a Regulatory Director/Sr. Director Regulatory CMC to lead global regulatory CMC submissions and ensure compliant health authority communications.

The role sits within Regulatory and partners with cross-functional teams to shape strategies for IND/CTA/MF and BLA/MAA filings. The position requires extensive experience in regulatory CMC, strong writing and leadership skills, and on-site presence 1-3 days per week.

Qualifications

• BA/BS degree in a scientific/engineering discipline with 15+ years experience, 10 of which in biotech.
• 9+ years experience in Regulatory CMC, with direct technical writing for IND/CTA/MF and BLA/MAA submissions.
• Experience with cell and gene therapy and/or lipid nanoparticles is desirable.

Responsibilities

• Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams.
• Develop and communicate CMC strategies, risks and key issues in a changing regulatory landscape.
• Act as the regulatory CMC lead in matrix teams for development programs.
• Support manufacturing, analytical, and supply chain strategies with regulatory guidance.
• Define CMC content requirements for quality sections of regulatory dossiers.
• Plan and manage high-quality CMC-related submission elements and ensure compliance.
• Review detailed scientific information in CMC documents and justify conclusions with data.
• Evaluate CMC-related change proposals for regulatory impact and filing needs.
• Develop regulatory processes and templates; lead global health authority interactions.
• Support GMP and pre-approval inspections and maintain stakeholder partnerships.

Skills

Regulatory leadership

Regulatory strategy

CTD experience

Cross-functional collaboration

Regulatory intelligence

Communication skills

Global filings

Education

BA/BS in scientific/engineering discipline

Job description

Beam Therapeutics is seeking a Regulatory Director/Sr. Director Regulatory CMC to lead global regulatory CMC submissions and ensure compliant health authority communications.

The role sits within Regulatory and partners with cross-functional teams to shape strategies for IND/CTA/MF and BLA/MAA filings. The position requires extensive experience in regulatory CMC, strong writing and leadership skills, and on-site presence 1-3 days per week.