Regulatory Affairs Associate

Verastem Oncology

. Compile, format, quality check, and track documents for FDA submissions, including IND and NDA submissions and amendments .

Posted 10/22/2026full-timeBoston • Massachusetts • United StatesJuniorMid-Level💰 $85,000 - $100,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates proficiency in FDA regulatory processes, good documentation practices, and cGMP principles while effectively coordinating with cross-functional teams to ensure timely and accurate submissions. Strong attention to detail and clear written communication are essential for maintaining compliance and quality in regulated documentation.

Highest-signal resume keywords

FDA Submission SupportRegulatory DocumentationGood Documentation PracticesMicrosoft Word and Excel ProficiencyCGMP Principles

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsQuality Records ManagementSubmission Records HandlingStandard Operating ProceduresData Integrity PrinciplesVersion ControlDocument FormattingQuality CheckDocument TrackingRegulatory Forms Preparation

Soft Skills

Attention to DetailClear Written CommunicationSound OrganizationCoordination with Colleagues

Tools & Technologies

Veeva RIMVeeva QualityDocsElectronic Document Systems

Industry Keywords

IND SubmissionsNDA SubmissionsFDA GuidanceRegulated LaboratoryPharmaceutical QualityBiotechnologyLife Sciences

About the role

Key responsibilities & impact

Compile, format, quality check, and track documents for FDA submissions, including IND and NDA submissions and amendments
Prepare, quality check, publish, and track FDA promotional material submissions, including Form FDA 2253 and applicable pre-dissemination submissions
Maintain submission logs, document inventories, timelines, electronic records, and submission acknowledgments
Check materials for completeness, version control, and consistency before review
Prepare and update regulatory forms, correspondence, and supporting documents under senior regulatory staff guidance
Coordinate with clinical, quality, manufacturing, and other contributors to collect documents, follow up on comments, and support submission deadlines
Monitor and summarize FDA guidance, regulatory developments, and publicly available review findings
Support controlled-document activities, including drafting or revising standard operating procedures and tracking review and approval in electronic document systems
Apply good documentation practices, data integrity principles, and applicable cGMP requirements when handling regulated records
Escalate missing information, discrepancies, and potential compliance concerns

Requirements

What you’ll need

Bachelor’s degree in biochemistry, biotechnology, biology, pharmaceutical sciences, pharmacy, regulatory or life science
Entry-level experience; relevant internships, co-ops, or academic projects in regulatory affairs, pharmaceutical quality, biotechnology, or a regulated laboratory count as experience
Exposure to regulated documentation, such as submission records, quality records, standard operating procedures, specifications, or investigation records
Strong attention to detail, clear written communication, sound organization, and the ability to coordinate with colleagues across functions
Proficiency with Microsoft Word and Excel and the ability to learn electronic regulatory and quality document systems
Foundational understanding of FDA regulatory processes, good documentation practices, data integrity, and cGMP principles
Anticipated travel of 3 consecutive weekdays per month to the Verastem Corporate Office in MA
Preferred: Hands-on exposure to FDA submission support or IND documentation
Preferred: Experience with Veeva RIM, Veeva QualityDocs, or similar systems
Preferred: Experience reviewing controlled documents, maintaining traceable electronic records, analyzing quality or regulatory trends, or presenting findings to colleagues