Regulatory Affairs Associate

Verastem • Boston, MA

3d • $85,000 - $100,000

About The Position

The Regulatory Affairs Associate supports the preparation, submission, and maintenance of regulatory documents for pharmaceutical products. Working with regulatory, quality, clinical, and technical stakeholders, the associate helps ensure submission materials are accurate, organized, traceable, and ready for review. The position is suited to a recent graduate with relevant internship or co-op experience in regulatory affairs or pharmaceutical quality.

The role includes assisting with FDA submissions and promotional material submissions; maintaining submission records and timelines; supporting regulatory forms and correspondence; coordinating document collection and review across teams; monitoring relevant FDA guidance and regulatory developments; and supporting controlled-document activities. The associate applies good documentation practices, data integrity principles, and applicable cGMP requirements when handling regulated records, and escalates missing information, discrepancies, or potential compliance concerns.

Anticipated travel is three consecutive weekdays per month to Verastem’s corporate office in Massachusetts.

Requirements

• Bachelor’s degree in biochemistry, biotechnology, biology, pharmaceutical sciences, pharmacy, regulatory affairs, or a 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 ability to coordinate with colleagues across functions.
• Proficiency with Microsoft Word and Excel and ability to learn electronic regulatory and quality document systems.
• Foundational understanding of FDA regulatory processes, good documentation practices, data integrity, and cGMP principles.

Nice To Haves

• Hands-on exposure to FDA submission support or IND documentation.
• Experience with Veeva RIM, Veeva QualityDocs, or similar systems.
• Experience reviewing controlled documents, maintaining traceable electronic records, analyzing quality or regulatory trends, or presenting findings to colleagues.

Responsibilities

• Assist with compiling, formatting, quality checking, and tracking documents for FDA submissions, including IND and NDA submissions and amendments, as applicable to the company’s portfolio.
• Partner with Regulatory Advertising and Promotion to prepare, quality check, publish, and track FDA promotional material submissions, including Form FDA 2253 and applicable pre-dissemination submissions; maintain submission records and acknowledgments.
• Maintain regulatory submission logs, document inventories, timelines, and electronic records; check materials for completeness, version control, and consistency before review.
• Support preparation and updating of regulatory forms, correspondence, and supporting documents under the guidance of senior regulatory staff.
• Coordinate with clinical, quality, manufacturing, and other contributors to collect documents, follow up on comments, and support submission deadlines.
• Monitor and summarize relevant FDA guidance, regulatory developments, and publicly available review findings to help identify recurring issues and potential submission risks.
• 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 to the appropriate team member.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level