Regulatory Operations Associate – eCTD Publishing (CMC)

Title: Regulatory Operations Associate – eCTD Publishing (CMC)

Location: Greater Boston Area, MA (Hybrid 3 days onsite)

Employment Type: Contract

Status: Accepting Candidates

About the Role

Join a collaborative Regulatory Affairs team supporting critical health authority submissions in a fast-paced biopharmaceutical environment. This role focuses on eCTD Publishing, Submission Management, and regulatory documentation activities to ensure timely, accurate, and compliant submissions.

Key Responsibilities

• Support planning, coordination, and execution of regulatory submissions, including INDs, IMPDs, amendments, and annual reports.
• Prepare regulatory documents for eCTD Publishing and ensure submission-ready formatting.
• Perform quality checks on bookmarks, hyperlinks, tables of contents, file naming conventions, and document properties.
• Support assembly and QC review of electronic submission packages in collaboration with internal teams and publishing vendors.
• Track submission timelines, deliverables, and milestones to support on-time execution.
• Maintain regulatory documentation, submission archives, correspondence logs, and regulatory tracking systems.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field.
• 2–5 years of Regulatory Affairs or Regulatory Operations experience.
• Experience supporting electronic regulatory submissions and document preparation in a regulated environment.
• Familiarity with eCTD Publishing, submission-ready documents, and regulatory submission processes.
• Proficiency with Microsoft Office; experience with Veeva RIM preferred.
• Strong organizational skills, attention to detail, and ability to manage multiple deadlines.

Compensation (MA Pay Transparency):

• Estimated hourly range: $45–$55/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.