Vertex Inc.Boston, Massachusetts, United States · Hybrid
$190k–$286k/yr
Job Description General Summary: The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and …
Skills: Regulatory strategy, CMC regulatory affairs, Small molecule development, Health authority interaction, Strategic leadership
Vertex Inc.Boston, Massachusetts, United States · Hybrid
$160k–$240k/yr
Job Description General Summary: The Associate Director, Technical Services is accountable for the technical execution of biologics drug substance manufacturing at external manufacturing partners. This role is responsibl…
Skills: Biologics Manufacturing, cGMP Operations, Deviation Management, Technical Troubleshooting, Aseptic Manufacturing
Vertex Inc.Boston, Massachusetts, United States · Hybrid
$156k–$234k/yr
Job Description The Associate Director, Nonclinical Sciences Program Management & Strategic Operations (PMSO) is responsible for the integration, planning, coordination, and execution of complex pharmaceutical developmen…
Skills: Project Management, Strategic Operations, GLP Regulations, Pharmaceutical Drug Discovery, Preclinical Development
Boston, Massachusetts, United States · On-site
$29/hr
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As …
Skills: Laboratory techniques, Sample preparation, Data analysis, Statistical methods, Laboratory equipment maintenance
Vertex Inc.Boston, Massachusetts, United States · Hybrid
$185k–$277k/yr
Job Description General Summary: The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites including evaluating, improving, and monitoring commercial level …
Skills: GMP Compliance, Inspection Readiness, Inspection Management, Risk Management, Quality Governance
Vertex Inc.Boston, Massachusetts, United States · Hybrid
$198k–$297k/yr
Job Description General Summary: This role leads a team responsible for the architecture, delivery, security, support, and continuous evolution of enterprise laboratory technology platforms across LC1/2, Vertex's Cell & …
Skills: Stakeholder Management, Cell & Gene Therapy, Enterprise Technology Operations, Cyber Security, ITSM
San Francisco, California, United States · On-site
$130k–$194k/yr
Our team is looking for a Research Strategist to help execute research strategy, working closely in a collaborative environment. You will deliver actionable insights that guide decisions as we create engaging and custome…
Skills: User research, Behavioral science, Experimental design, Quantitative research, Qualitative research
Rhythm Pharmaceuticals Inc.Boston, Massachusetts, United States · Hybrid
$135k–$215k/yr
Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or…
Skills: Publication management, Project management, Medical communications, Scientific writing, Manuscript submission
UMass Boston - College of ManagementBoston, Massachusetts, United States · On-site
General Summary: The Senior Research Associate will play a leadership role in advancing the National Collaboratory to Address Elder Mistreatment (NCAEM), Phase IV: Integrating Elder Mistreatment Prevention and Interventi…
Skills: Project management, Quantitative research, Qualitative research, Survey design, Data management
Vertex Inc.Boston, Massachusetts, United States · Hybrid
$232k–$348k/yr
Job Description General Summary: The Senior Director, Clinical Pharmacology will serve as a Disease Area leader for Clinical Pharmacology. The Senior Director, Clinical Pharmacology will also manage the scientific functi…
Skills: Clinical Pharmacology, Pharmacometrics, Regulatory Agency Interactions, IND Packages, NDA/MAA Support
Vertex Inc.Boston, Massachusetts, United States · Hybrid
$192k–$288k/yr
Job Description General Summary: The Director, Regulatory Data is responsible for leading the strategy, governance, execution, and continuous improvement of regulatory data management within Vertex’s Regulatory Informati…
Skills: Regulatory Information Management, GxP Data Management, Stakeholder Management, Change Management, Project Management
Vertex Inc.Boston, Massachusetts, United States · Hybrid
$190k–$286k/yr
Job Description General Summary: The Director, Global Submission Management (GSM) is responsible for the strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle …
Skills: Global Regulatory Submissions, Project Management, Stakeholder Management, Cross-functional Communication, Risk Management
Vertex Inc.Boston, Massachusetts, United States · Remote OK
$186k–$278k/yr
Job Description General Summary: The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products. This role will be responsible for the development and maintenance…
Skills: Global Labeling Strategy, Regulatory Affairs, CCDS Development, Health Authority Negotiation, Lifecycle Management
Vertex Inc.Boston, Massachusetts, United States · Hybrid
$193k–$289k/yr
Job Description Our Medical Writing team at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams, authoring and driving clinical & regulato…
Skills: Medical writing, Clinical development, Regulatory submissions, Strategic planning, Team leadership
South San Francisco, California, United States · On-site
$40k–$111k/yr
Job Description The Future Talent Program features internships that last 10-12 weeks and will include one or more projects. These opportunities in our Research Division can provide you with great development and a chance…
Skills: Analytical chemistry, Laboratory instrumentation, Data analysis, Mass spectrometry, NMR techniques
Vertex Inc.Boston, Massachusetts, United States · Hybrid
$163k–$244k/yr
Job Description General Summary: The Health Systems / HCP Marketing Associate Director is responsible for the development and execution of key personal and non-personal promotion marketing tactics targeting Health System…
Skills: Marketing strategy, Health systems marketing, Formulary decision maker messaging, Digital media strategy, Value proposition development
Vertex Inc.Boston, Massachusetts, United States · Hybrid
$163k–$245k/yr
Job Description General Summary: The Associate Director, Global Submission Management (GSM) is responsible for the strategic oversight and execution of a portfolio of global regulatory submissions across development and …
Skills: Global Regulatory Submission Management, Project Management, Stakeholder Management, Cross-functional Communication, Risk Management
Vertex Inc.Boston, Massachusetts, United States · Hybrid
$116k–$174k/yr
Job Description The Manager, Disease Strategy Finance is a key member of Vertex's Disease Strategy Finance Team, providing financial and strategic insights to inform Disease Strategy Teams (“DSTs”) on key decisions. This…
Skills: Financial modeling, Forecasting, Scenario-based valuation, Budgeting, Long-term planning
Vertex Inc.Boston, Massachusetts, United States · Remote OK
Job Description General Summary: The Patient Safety Epidemiology Associate Director leads safety and regulatory epidemiology activities for Vertex products across multiple therapeutic areas and throughout all phases of l…
Skills: Pharmacoepidemiologic methods, Pharmacovigilance, Regulatory affairs, Study design, Observational research
Boston, Massachusetts, United States · Hybrid
$40k–$111k/yr
Job Description The Future Talent Program features internships that last 10-12 weeks and will include one or more projects. These opportunities can provide you with great development and a chance to see if we are the rig…
Skills: Epidemiology, Biostatistics, Data Analysis, Real-world Evidence, SAS
Vertex Inc.
Boston, Massachusetts, United States • Hybrid
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The Director leads global regulatory CMC strategies for small molecule products and oversees interactions with health authorities. They are responsible for driving organizational excellence through talent development and the integration of AI-enabled technologies into regulatory processes.
Candidates must have a bachelor's degree in a life sciences discipline and over 10 years of industry experience in small molecule development. Proven experience in leading global CMC regulatory strategies and at least 3 years of people management are required.
The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio. This role provides strategic leadership for complex regulatory CMC activities, oversees Health Authority engagement, and ensures regulatory requirements are effectively integrated into development and commercialization plans. The Director drives organizational excellence through talent development, process innovation, and the application of digital and AI-enabled capabilities to enhance the quality, consistency, and efficiency of regulatory decision-making, document preparation, and submission execution.
LI-EE1 LI-Hybrid
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.
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.
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
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
When it has to be right, you Vertex™.
Vertex is the Decision-to-Defense™ global indirect tax and compliance company. We help enterprises control indirect tax and compliance across the transaction lifecycle-so outcomes can be proved and improved with confidence. Our purpose is to ensure businesses and communities thrive through trusted transactions. Global compliance now lives inside the transaction. So does Vertex-helping enterprises prove outcomes from determination to defense.
Offices: 2301 Renaissance Blvd, King of Prussia, PA 19406, US · 40 Shuman Blvd., Suite 218, Naperville, IL 60540, US · 1 Furzeground Way, Stockley Park, Stockley Park, Uxbridge UB11 1EZ, GB · 101 Arthur Andersen Parkway, Suite 300, Sarasota, FL 34232, US · Gustav Mahlerplein, Amsterdam, North Holland 1082, NL
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