Regulatory Affairs Associate

Company Profile:

At Verastem Oncology, we address urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We’ve launched this novel/novel combination therapy in the U.S. and are exploring pathways for Europe and Japan. We continue to advance our pipeline of drugs to help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. This is an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients.

Position Summary

The Regulatory Affairs Associate supports the preparation, submission, and maintenance of regulatory documents for pharmaceutical products. The associate works closely with various stakeholders including regulatory, quality, clinical, and technical teams, to assist in keeping submission materials accurate, organized, traceable, and ready for review. This role is suited to a recent graduate with relevant internship or co-op experience in regulatory affairs or pharmaceutical quality.

Core Responsibilities

- Assist with compiling, formatting, quality checking, and tracking documents for FDA submissions, including investigational new drug (IND), new drug application (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, while maintaining accurate 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 the team 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 current good manufacturing practice (cGMP) requirements when handling regulated records.

- Escalate missing information, discrepancies, and potential compliance concerns to the appropriate team member.

- Anticipated travel of 3 consecutive weekdays per month to the Verastem Corporate Office in MA.

Required Education and Experience

- 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.

Preferred qualifications

- 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.