Associate Director, CMC Regulatory Affairs - Biologics

Location: Remote – US-based candidates only, no visa sponsorship available

Compensation: $150,000 – $195,000 annually

About the role

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a life sciences environment.

Responsibilities

• Develop and execute global CMC regulatory strategies for biologics throughout their lifecycle
• Lead cross-functional teams to align CMC activities with regulatory goals and timelines
• Assess regulatory risks and create mitigation strategies for global development programs
• Prepare and submit CMC content for regulatory filings globally, ensuring compliance and quality
• Manage CMC interactions with health authorities and support major registration milestones
• Advise on regulatory considerations for biologics from development to commercialization
• Provide oversight on analytical characterization and comparability assessments

Qualifications

• Bachelor's degree in Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field; advanced degree preferred
• 8+ years of regulatory affairs experience within biotechnology or pharmaceutical, with a focus on CMC
• Strong technical expertise in biologics development from clinical to commercialization phases, including post-approval
• Experience with global regulatory submissions like INDs, BLAs, MAAs, and others
• Comprehensive understanding of FDA, EMA, and other regulatory requirements

Benefits

• Comprehensive health and wellness offerings for employees and dependents
• Life insurance and disability coverage included
• Retirement plans with employer matching contributions
• Generous paid time off and employee support programs