Associate Director, Regulatory CMC, Biologics

Leads and executes global regulatory Chemistry Manufacturing Controls (CMC) strategies for investigational and commercial biologics products. Accountable for authoring, reviewing, and delivering high-quality regulatory submissions while serving as the primary CMC interface with Health Authorities. Integrates advanced digital and AI-enabled approaches to enhance regulatory document preparation and efficiency.

Responsibilities

• Leads preparation, review, and lifecycle management of CMC sections of global regulatory submissions for biologics (INDs/CTAs, NDAs/BLAs/MAAs)
• Develops and drives global CMC regulatory strategies for assigned programs
• Serves as primary regulatory CMC lead for Health Authority interactions
• Provides regulatory guidance to cross-functional teams
• Leads regulatory assessment of CMC changes, deviations, and investigations
• Applies AI-enabled tools for authoring, review, and consistency checks
• Drives structured content and data traceability approaches
• Supports AI/digital capability development
• Contributes to process improvements and innovation initiatives
• Represents Regulatory CMC in governance forums
• Stays abreast of and adopts emerging technologies, including AI, to strengthen regulatory CMC's decision-making and innovation
• Proactively remains up to date on advances in technology, AI, automation, competitive intelligence, and changes in the regulatory environment

Requirements

• Advanced knowledge of global regulatory CMC requirements (FDA, EMA, ICH, Health Canada) for biologics
• Strategic thinking and problem-solving skills
• Excellent communication skills
• Ability to lead and influence cross-functional teams
• Strong planning and prioritization skills
• Ability to work in a global matrixed environment
• Commitment to quality and compliance
• Working knowledge of AI tools for regulatory document preparation and review
• Experience with structured content and data-driven authoring
• Ability to critically review AI-assisted outputs
• Familiarity with digital submission and data integrity expectations
• Ability to identify automation and AI opportunities
• May include people management responsibilities

Qualifications

• Bachelor’s degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field (advanced degree preferred)
• 8+ years of experience in the pharmaceutical or biotechnology industry with a focus on biologics
• Experience leading CMC regulatory submissions and Health Authority interactions for biologics
• Experience with complex or multi-product strategies preferred

Pay

Pay range: $166,400 - $249,600. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.

Benefits

• Medical, dental, and vision benefits
• Generous paid time off, including a week-long company shutdown in the Summer and Winter
• Educational assistance programs, including student loan repayment
• Generous commuting subsidy
• Matching charitable donations
• 401(k) retirement plan

Schedule

Hybrid-eligible: work remotely up to two days per week, or choose on-site work five days per week with ad hoc flexibility.