Regulatory Affairs Co-Op -Northeastern University Students (PharmD)

 

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com.

The Regulatory Associate (Student Co-op) will support the Regulatory Lead in planning, coordinating, and executing regulatory activities across product development and lifecycle management. This role requires a detail-oriented, organized professional eager to learn US regulatory processes and contribute to timely, high-quality submissions while ensuring compliance with internal procedures and health authority requirements.

The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a 'we own it' mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston’s Seaport area, with a strong preference for being onsite 3-4 days per week.

Key Responsibilities

• Submission support:
• Assist in authoring, formatting, QC, and assembly of regulatory submissions (e.g., IND, CTA, amendments, annual reports) using eCTD standards.
• Coordinate cross-functional inputs (CMC, Nonclinical, Clinical, PV, QA) and manage document trackers, version control, and timelines.
• Prepare and maintain submission-ready documents (templates, cover letters, forms)
• Health Authority Interactions
• Assist with meeting preparation (eg P-IND, IND development briefing packages, slides, meeting minutes, action logs) for health authority meetings.
• Track and assist in management of health authority requests for information (RFI) deficiency responses, and commitments; coordinate internal response teams and timelines.
• Regulatory Document archive system support
• Assist and coordinate archival of regulatory documents into archive system (Veeva Vault RIM)
• Provide general support for Regulatory Leads across programs, as needed.

Qualifications

• Current Doctorate of Pharmacy Student
• Previous experience in regulatory affairs is preferred but not required for this role.
• Demonstrated interest in Regulatory Affairs
• Strong attention to detail, organizational skills, and ability to manage multiple tasks in a fast-paced environment.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft 365 (Word, Excel, PowerPoint, Teams) and aptitude for learning document management systems.
• Demonstrated ability to work collaboratively and to seek guidance appropriately.
• Internship/co-op or 0–1 year experience in Regulatory Affairs, Quality, Clinical Operations, or related function.
• Preferred: Familiarity with eCTD structure, submission components, and common regulatory documents (Module 1–5, protocols, investigator brochures, study reports).
• Preferred: Familiarity with Veeva Vault systems, specifical Regulatory Information Management (RIM).
• Preferred: Exposure to ICH guidelines (e.g., ICH E6(R2/R3), M4 CTD, Q-series), FDA and EMA regulatory frameworks, and basic GxP principles.