New · posted Nov 12
Vertex Pharmaceuticals · Biotechnology
Associate Director, Regulatory Technology
- Boston, MA
- Hybrid
- Full-time
- Director
The role
The Associate Director, Regulatory Technology is accountable for translating Regulatory priorities into an actionable technology roadmap across Regulatory-owned platforms. The role owns demand intake, prioritization, release planning, and enhancement delivery; serves as the primary business liaison to Digital Technology and Engineering (DTE) teams; and advances Regulatory capabilities through AI, automation, and emerging technologies. Working across Regulatory, DTE, and business stakeholders, the Associate Director helps ensure technology investments are aligned, scalable, compliant, and positioned to deliver measurable business value.
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
Required Education Level
Bachelor's degree in life sciences, information technology, engineering, business, or a related field.
Required Experience
- Typically requires 8 years of relevant experience in regulatory technology, regulatory operations, product management, business technology, or a related area within the pharmaceutical or biotechnology industry, or the equivalent combination of education and experience.
- Demonstrated experience managing technology roadmaps, demand intake, prioritization, release planning, and enhancement delivery across a portfolio of business platforms.
- Experience partnering with enterprise technology teams and cross-functional business stakeholders to deliver technology-enabled capabilities in a regulated environmen.
- Experience evaluating or implementing AI, automation, or other emerging technologies, including pilots and scale-up planning.
Required Knowlede/Skills
- Strong product and portfolio management capabilities, including roadmap development, demand management, prioritization, release planning, and value realization.
- Working knowledge of Regulatory Affairs and Regulatory Operations processes, data, content, and technology within the pharmaceutical or biotechnology industry.
- Strong technical expertise in Veeva Vault RIM and integrations across the Veeva suite, including Veeva Quality, Clinical, and PromoMats.
- Ability to translate business needs into clear, outcome-focused requirements and to communicate effectively with both business and technical audiences.
- Strong stakeholder management, facilitation, influencing, and decision-making skills across organizational levels and functions.
- Demonstrated ability to manage multiple initiatives, dependencies, risks, and competing priorities in a complex environment.
- Knowledge of technology governance, software delivery practices, system lifecycle considerations, and compliance expectations for regulated platforms.
- Ability to identify practical applications for AI, automation, and emerging technologies while considering scalability, adoption, risk, and business value.
- Strong analytical, problem-solving, communication, and change management skills.
- Ability to work independently, exercise sound judgment, and lead through influence in a matrixed organization.
Other Requirements
- Ability to engage with global stakeholders across time zones as business needs require.
- Travel may be required based on business needs.
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.
What you'll do
- Maintain the Regulatory Technology roadmap across Regulatory-owned platforms, aligning planned capabilities and investments with Regulatory priorities and the broader technology strategy.
- Lead the end-to-end demand intake and prioritization process, partnering with business stakeholders to define needs, assess value, dependencies, risk, and readiness, and establish a transparent delivery sequence.
- Drive release planning and enhancement delivery across the platform portfolio, coordinating scope, business requirements, timelines, testing readiness, communications, and adoption activities with product owners and delivery teams.
- Serve as the primary Regulatory business liaison to DTE teams, translating business needs into clear technology requirements and facilitating timely decisions, issue resolution, and alignment across functions.
- Establish and facilitate appropriate roadmap and portfolio governance, providing clear visibility to priorities, delivery status, risks, dependencies, decisions, and expected outcomes.
- Drive innovation through AI, automation, and emerging technologies by identifying high-value opportunities, shaping pilots, defining success measures, and advancing viable concepts toward scalable solutions.
- Partner with Regulatory process owners, data and technology teams, and end users to ensure solutions support compliant, efficient, and user-centered ways of working.
- Monitor regulatory technology trends, industry practices, and evolving business needs to inform roadmap choices and recommend future capabilities.
- Support change management and adoption by developing stakeholder engagement, communications, training, and feedback approaches appropriate to each release or initiative.
- Communicate roadmap progress, delivery outcomes, risks, and recommendations to Regulatory leadership and cross-functional stakeholders.
Pay and benefits
$164,000 – $246,000 a year
Employer provided$164,000 - $246,000
Medical, dental and vision benefits
Generous paid time off
Company shutdown in Summer and Winter
Student loan repayment and educational assistance
Commuting subsidy
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 · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Director roles in Massachusetts5 roles publishing pay
Director roles in the US13 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $164,000 | — | $246,000 |
| Massachusetts (middle half) | $198,500 | $205,000 | $227,500 |
| All US (middle half) | $198,500 | $205,000 | $227,500 |
This role: Vertex Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 43 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Vertex's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- Lab testing and methods2
- Data and digital systems2
- GMP and compliance1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Operations work in biotechnology, each linked to the agency or standards body that publishes it.
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
- FDAFDA Structured Product Labeling(official source, opens in a new tab)The SPL standard for submitting labeling content to FDA
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLA
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Vertex on Regulatory Jobs
- 46
- Open roles
- 46
- Distinct roles
- 2
- Locations
By discipline
- Clinical20 43%
- Quality16 35%
- Regulatory10 22%
By level
- Director38 83%
- Manager5 11%
- VP & Executive1 2%
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Associate Director, Regulatory Technology at Vertex
Applications close November 17. $164K–$246K a year, employer provided.