Associate Director, Regulatory CMC, Biologics

Job Description

General Summary:

The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and delivering high-quality regulatory submissions, while serving as the primary CMC interface with Health Authorities. The role integrates advanced digital and AI-enabled approaches to enhance the quality, consistency, and efficiency of regulatory document preparation and review.

Key Duties and 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, and maintains a continuous learning mindset 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.

Knowledge and Skills:

• Advanced knowledge of global regulatory CMC requirements (FDA, EMA, ICH, Health Canada) for biologics
• Strategic thinking and problem solving
• 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
• May include people management responsibilities

Digital & AI-Enabled Regulatory Capabilities

• 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

Education and Experience:

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

Pay Range:

$166,400 - $249,600

Disclosure Statement:

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid
 

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]