Regulatory Operations Associate

Regulatory Associate (CMC), Submission Management & Publishing Support

Location: Waltham, MA (Hybrid – 3 Days Onsite per Week)

Job Type: 6 month contract with opportunity to extend

Pay Rate: Up to $55 an hour or about $111,000 a year

Position Summary

The Regulatory Associate is responsible for supporting regulatory submission management, publishing, and regulatory documentation activities to ensure timely, accurate, and compliant Health Authority submissions. This role partners closely with Regulatory Affairs, cross-functional teams, and external publishing vendors to coordinate submission components, prepare dossiers for electronic submission, and maintain regulatory records in accordance with internal procedures and global regulatory requirements.

Key Responsibilities

Submission Management Support

• Support the planning, coordination, and execution of regulatory submissions, including INDs, IMPDs, amendments, annual reports, and other regulatory filings as applicable.
• Assist with the compilation and organization of submission content, ensuring deliverables are received from functional contributors according to established timelines.
• Track submission milestones, deliverables, and dependencies to support on-time execution.
• Maintain submission trackers, timelines, and status reports for internal stakeholders.
• Coordinate with cross-functional teams to ensure submission readiness and document completeness.

Publishing & Submission Support

• Prepare regulatory documents for publishing by ensuring compliance with technical and formatting requirements for electronic submissions.
• Perform pre-publishing quality checks, including verification of bookmarks, hyperlinks, document properties, tables of contents, and file naming conventions.
• Support the assembly of eCTD submission components in collaboration with internal teams and external publishing vendors.
• Conduct quality control reviews of published submission outputs to ensure completeness, accuracy, and compliance with regulatory standards.
• Assist in resolving publishing-related issues and supporting submission readiness activities.

Regulatory Documentation & Records Management

• Maintain regulatory documentation within document management systems, regulatory information management systems (RIM), and shared repositories.
• Support the maintenance of submission archives, Health Authority correspondence, communication logs, and regulatory trackers.
• Ensure regulatory records are organized, current, and inspection-ready.
• Assist with the maintenance and continuous improvement of work instructions, templates, departmental tools, and publishing processes.

Qualifications

Education

• Bachelor's degree in Life Sciences, Regulatory Affairs, or a related scientific discipline required.

Experience

• 2–5 years of Regulatory Affairs experience within the pharmaceutical, biotechnology, or life sciences industry.
• Experience supporting electronic regulatory submissions and document preparation in a regulated environment.
• Familiarity with eCTD structure, electronic publishing processes, and submission-ready document requirements preferred.
• Experience working with Health Authority submissions and regulatory documentation management is highly desirable.

Required Skills & Competencies

• Strong organizational and project coordination skills with the ability to manage multiple priorities and deadlines simultaneously.
• Exceptional attention to detail and commitment to document quality and accuracy.
• Understanding of regulatory submission processes, publishing activities, and document lifecycle management.
• Ability to work effectively in a fast-paced, cross-functional environment.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint.
• Experience with Veeva RIM or similar Regulatory Information Management Systems preferred.
• Ability to identify issues proactively and support timely resolution.
• Demonstrated ability to maintain confidentiality and handle sensitive regulatory documentation appropriately.

Preferred Background

• Experience supporting CMC regulatory submissions.
• Exposure to global regulatory submission processes and Health Authority interactions.
• Experience collaborating with external publishing vendors and managing submission deliverables.