Director, Regulatory CMC – Global Gene Therapy

Panda International; Boston (MA); On-site; USD 230,000 - 260,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401(k) with company match

15 days PTO with rollover + holidays

Tuition reimbursement

Wellbeing benefits

Job summary

Panda International, a clinical-stage biotech focused on AAV gene therapies, is seeking a Director of Regulatory CMC to own global regulatory strategy across the portfolio. You will lead CMC discussions with health authorities, shape lifecycle plans, and partner with executive leadership to drive programs from clinical development to commercial readiness.

You will guide GMP, validation, comparability and tech transfer across sites, and manage interactions with FDA/EMA and other agencies while

Qualifications

• BS, MS, PhD or PharmD in a scientific discipline.
• 12+ years in Regulatory Affairs with substantial Regulatory CMC responsibility for biological products.
• Hands-on experience leading FDA and/or EMA interactions.
• Strong knowledge of GMP manufacturing, process validation, analytical development, comparability and quality systems.
• Experience leading cross-functional teams in a fast-moving biotech.

Responsibilities

• Build and execute global Regulatory CMC strategies for clinical and late-stage programs.
• Lead CMC planning for marketing applications (BLA/MAA) and geographic expansion.
• Guide manufacturing changes, comparability, tech transfer and network expansion.
• Act as CMC lead for FDA, EMA, MHRA, PMDA, Health Canada and other agencies.
• Translate evolving regulatory guidance into practical program strategy and advise executives on regulatory risk.
• Shape post-approval lifecycle strategies that keep operations flexible while staying compliant.
• Help build the Regulatory CMC function as the company moves toward commercial stage.

Skills

Regulatory CMC leadership

Global strategy

FDA/EMA interactions

Cross-functional leadership

Quality systems

Education

Scientific degree (BS/MS/PhD or PharmD)

Job description

Panda International, a clinical-stage biotech focused on AAV gene therapies, is seeking a Director of Regulatory CMC to own global regulatory strategy across the portfolio. You will lead CMC discussions with health authorities, shape lifecycle plans, and partner with executive leadership to drive programs from clinical development to commercial readiness.

You will guide GMP, validation, comparability and tech transfer across sites, and manage interactions with FDA/EMA and other agencies while