Associate Director​/Director, Regulatory Affairs, Burlington, MA

Associate Director / Director, Regulatory Affairs, Burlington, MA Position Summary

Cell Centric is seeking a highly motivated regulatory leader with significant experience to support regulatory strategy for a clinical-stage oncology asset progressing toward registration, including potential for expansion into additional indications.

This individual will contribute to the development and execution of regulatory strategy, lead key health authority interactions, and serve as a strategic partner to Clinical Development, CMC, and cross-functional teams. The level of strategic ownership and independence will be aligned with experience (Associate Director or Director).

The ideal candidate thrives in a science-driven, fast-paced biotech environment and brings strong understanding of clinical-stage regulatory strategy for life-threatening diseases and IND lifecycle management; oncology experience preferred but not required.

• Develop and execute regulatory strategies to support high priority oncology development program
• Serve as regulatory lead on cross-functional program teams
• Provide regulatory input into clinical protocol design, endpoint strategy, and overall development planning
• Identify regulatory risks and develop mitigation strategies
• Serve as primary contact with FDA and support interactions with other global health authorities
• Lead preparation and coordination of regulatory agency interactions (e.g., Type B, EOP2, Pre-NDA meetings)
• Author and oversee briefing documents and meeting requests
• Provide oversight of IND lifecycle management, including amendments and annual reports
• Lead preparation and submission of INDs/CTAs and support NDA/MAA readiness
• Ensure global submissions are compliant with regional regulatory requirements (US, EU, UK)
• Develop strategies for expedited programs (Fast Track, Breakthrough Therapy, Orphan Drug Designation)
• Support pediatric regulatory planning (PSPs/PIPs) in oncology
• Monitor and interpret evolving oncology regulatory guidance
• Provide oversight of regulatory CRO partners
• Establish effective working models and ensure high-quality deliverables

• Required
• Bachelor’s degree in scientific discipline, advanced degree preferred
• 7+ years (Associate Director) or 9+ years (Director) of regulatory affairs experience in biotech or pharma
• Direct experience supporting or leading FDA Sponsor meetings and creation of supporting documents (meeting request, briefing documents, etc.)
• Demonstrated experience independently managing the IND lifecycle and leading regulatory strategy for clinical-stage programs
• Experience working in a clinical-stage biotech environment
• Excellent written and verbal communication skills
• Preferred
• Oncology regulatory experience preferred (hematologic malignancies and/or solid tumors)
• Experience in serious or rare disease development also highly valued
• Experience with expedited oncology programs (Fast Track, Breakthrough, Orphan)
• Global regulatory experience (EU/UK)
• Experience in biomarker-driven or precision oncology programs

• Trust and Respect:
  Act with integrity, honesty, and openness to build strong, credible relationships.
• Communication and Feedback:
  Share information clearly, listen actively, and engage in a culture of constructive feedback.
• Accountability and Reliability:
  Take ownership for performance, be dependable, and support others to achieve collective goals.
• Objectivity:
  Align on common objectives and use facts and data to reach fair, effective decisions.
• Team Balance and Enablement:
  Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential.