Director, CMC Regulatory (On-site role)

Role And Responsibilities

• Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through NDA/MAA and lifecycle management)
• Provide strategic input and regulatory guidance on manufacturing changes, comparability approaches, and control strategies
• Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (e.g. FDA, EMA, Health Canada, PMDA)
• Lead preparation and authorship of CMC sections (Module 2.3, 3) for: INDs/CTAs/Amendments
• Lead preparation of CMC Briefing documents and health authority interactions
• NDA/MAA and supplements/variations preparation and submissions
• Ensure alignment of CMC documentation with overall regulatory strategy and program timelines
• Oversee document quality, consistency, and compliance with global regulatory requirements
• Represent regulatory in change control assessments
• Support inspection readiness activities in collaboration with Quality and Manufacturing teams

Qualifications And Education Requirements

• Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred
• Minimum of 10+ years of regulatory affairs experience in biotech/pharma
• Preferred Skills: Experience supporting small molecules required (familiarity with additional modalities desirable); experience with IND/CTA, NDA/MAA compilation and submissions; deep knowledge of CMC development for small molecules, Module 3 structure and expectations, and comparability and change management strategies; familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines); proven ability to operate effectively in a small, fast-paced biotech environment; strong cross-functional leadership and influencing skills without direct authority; excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies

Salary Range

$230,000 to $270,000