Associate Director, Regulatory CMC, Biologics

vrtx· Vertex Pharmaceuticals Inc (US)
Apply Now ↗
📍 Boston, MAFull time💰 USD 166K–250K

About this role

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


At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

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 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 ApplicationAssistance@vrtx.com

Frequently Asked Questions

What is the salary for the Associate Director, Regulatory CMC, Biologics role at vrtx?
The listed salary for this Associate Director, Regulatory CMC, Biologics position at vrtx is USD 166K–250K. This is an Full time role.
Where is the Associate Director, Regulatory CMC, Biologics position at vrtx located?
This Associate Director, Regulatory CMC, Biologics role at vrtx is based in Boston, MA. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Associate Director, Regulatory CMC, Biologics role at vrtx full-time or part-time?
This is listed as a Full time position. It is posted as a Associate Director, Regulatory CMC, Biologics role in the Vertex Pharmaceuticals Inc (US) department at vrtx.
Which team or department does the Associate Director, Regulatory CMC, Biologics at vrtx belong to?
This Associate Director, Regulatory CMC, Biologics position is part of the Vertex Pharmaceuticals Inc (US) department at vrtx. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Associate Director, Regulatory CMC, Biologics position at vrtx?
Click the "Apply Now" button on this page. You will be redirected to vrtx's official application portal hosted on workday where you can submit your application directly.
When was the Associate Director, Regulatory CMC, Biologics job at vrtx posted?
This Associate Director, Regulatory CMC, Biologics position at vrtx was posted on Sep 8, 2026. Apply as soon as possible — early applications are often reviewed first.
Associate Director, Regulatory CMC, Biologics
vrtx · 💰 USD 166K–250K
Apply for this role ↗

You'll be redirected to vrtx's official application page on Workday.