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:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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…