Director, Regulatory CMC

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

About our client

Our client is a clinical-stage biotech developing AAV gene therapies for rare, life-threatening neuromuscular and cardiac diseases. The company has a strong patient focus. It is moving its lead programs toward pivotal development, registration and commercial launch, and is growing its Regulatory CMC team for that next stage.

The role

As Director, Regulatory CMC, you’ll own global CMC regulatory strategy across the AAV portfolio. You’ll be the regulatory voice within Technical Operations and Quality and work closely with Program Leadership and the executive team. You’ll also lead CMC discussions with health authorities worldwide. Here, Regulatory CMC is a respected technical partner, not just a submissions function.

What you’ll do

• Build and execute global Regulatory CMC strategies for clinical and late-stage programs, and represent CMC on cross-functional development and governance teams
• Lead CMC planning for marketing applications (BLA/MAA) and geographic expansion: control strategies, validation, potency methods and commercial specifications
• Guide manufacturing changes, comparability, tech transfer and network expansion across internal and external manufacturing sites
• Act as CMC lead for FDA, EMA, MHRA, PMDA, Health Canada and other agencies: briefing packages, responses and meeting strategy
• Turn changing guidance for advanced therapies 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, and represent it in industry consortia and gene therapy working groups

What you bring

• BS, MS, PhD or PharmD in a scientific discipline
• 12+ years in Regulatory Affairs, with substantial Regulatory CMC responsibility for biological products (required)A track record leading global CMC strategy for biologics, including registration-enabling programs and marketing applications
• 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

Strongly preferred

• Direct AAV gene therapy experience: vector characterization, potency assays, comparability and commercial manufacturing strategy
• BLA preparation, review and post-approval lifecycle management
• EU development strategy, including scientific advice and commercial readiness
• Experience with pre-approval inspections and launch readiness
• Background in rare genetic disease programs, ideally neuromuscular
• Experience in a company moving from clinical to commercial stage

What’s on offer

• Base salary of $230,000–$260,000, plus annual cash bonus and long-term equity
• Comprehensive medical, dental and vision coverage, with FSA/HSA options
• 401(k) with company match and an employee stock purchase plan
• 15 days PTO with rollover, 12 holidays, a floating holiday and a winter shutdown
• Tuition reimbursement and a range of wellbeing benefits