New · posted Oct 24
Vertex Pharmaceuticals · Biotechnology
Associate Director, CMC Regulatory Affairs
- Boston, MA
- Hybrid
- Full-time
- Director
The role
The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role also provides regulatory guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial products. This role may supervise other regulatory staff.
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]
What you need
- Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
- Typically requires 8 years of experience in the pharmaceutical or biotech industry or in a related field, or the equivalent combination of education and experience
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.
Knowledge and Skills
- Excellent interpersonal skills to communicate difficult concepts and persuade others
- Strategic thinking and strong problem solving skills
- Collaborates and communicates in an open, clear, complete, timely, and consistent manner
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines
What you'll do
- Leads the preparation and review of CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
- Develops global CMC regulatory strategies for one or more investigational and/or marketed products
- Leads regulatory colleagues in development of global CMC regulatory strategies and submissions
- Provides CMC regulatory guidance to cross-functional teams and key stakeholders
- Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
- Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
- Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise
Pay and benefits
$166,400 – $249,600 a year
Employer provided$166,400 - $249,600
Annual bonus
Annual equity awards
Medical, dental and vision benefits
Generous paid time off
Student loan repayment and educational assistance
401(k)
Where you'll work
Boston, MAHybridOpen in Maps (opens in a new tab)
More jobs in Boston, MAWorking conditions
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.
From the posting
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation.
Equal opportunity, accessibility and legal noticesVertex Pharmaceuticals's statements, word for word
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.
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.
Job intelligence
The context around this role
Live data · October 25, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in Massachusetts19 roles publishing pay
Director roles in the US45 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $166,400 | — | $249,600 |
| Massachusetts (middle half) | $199,250 | $217,500 | $246,250 |
| All US (middle half) | $191,000 | $208,000 | $230,000 |
This role: Vertex Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 25, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 87 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Vertex's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- Investigations and CAPA3
- Regulatory submissions3
- GMP and compliance1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Vertex on Regulatory Jobs
- 30
- Open roles
- 30
- Distinct roles
- 2
- Locations
By discipline
- Quality15 50%
- Regulatory9 30%
- Compliance & Safety6 20%
By level
- Director26 87%
- Manager2 7%
- VP & Executive1 3%
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Associate Director, CMC Regulatory Affairs at Vertex
Open until filled. $166K–$250K a year, employer provided.