CMC Regulatory Affairs Associate

About the Job

Title: CMC Regulatory Affairs Associate

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

Employment Type: Contract (6+ Months)

Status: Accepting Candidates

About the Role

We are seeking a CMC Regulatory Affairs to support regulatory submission management, publishing activities, and regulatory documentation processes within a fast-paced pharmaceutical environment. This role will work closely with Regulatory Affairs teams and cross-functional stakeholders to ensure timely, accurate, and compliant submissions to global Health Authorities. The ideal candidate will have experience supporting electronic regulatory submissions, eCTD publishing activities, and regulatory document management in a regulated industry.

Key Responsibilities

Regulatory Submission Support

• Support the planning, coordination, and execution of regulatory submissions, including INDs, IMPDs, amendments, and annual reports.
• Coordinate submission content and ensure deliverables are received from functional contributors according to established timelines.
• Track submission milestones, deliverables, and dependencies to support successful execution.
• Assist with preparation of submission trackers, timelines, and status updates.

Publishing & Submission Management

• Prepare regulatory documents for electronic submission by ensuring compliance with publishing standards and technical requirements.
• Perform pre-publishing quality checks including bookmarks, hyperlinks, document properties, table of contents, and file naming conventions.
• Support eCTD publishing activities and coordinate with internal teams and external publishing vendors.
• Conduct quality control reviews of submission packages to ensure completeness, accuracy, and regulatory compliance.

Regulatory Documentation & Records Management

• Maintain regulatory documentation within document management systems and regulatory information management systems.
• Support maintenance of submission archives, correspondence logs, regulatory trackers, and Health Authority communication records.
• Assist with management of departmental templates, procedures, and publishing tools.
• Ensure documentation is organized, accurate, and inspection-ready.

Cross-Functional Collaboration

• Partner with Regulatory Affairs, CMC, Quality, and other functional teams to support submission readiness.
• Communicate submission timelines, requirements, and status updates to stakeholders.
• Support process improvements related to submission management and publishing activities.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related discipline.
• 2–5 years of Regulatory Affairs or Regulatory Operations experience.
• Experience supporting regulatory submissions in a regulated pharmaceutical or biotechnology environment.
• Familiarity with electronic submission processes and regulatory publishing requirements.
• Understanding of document lifecycle management and regulatory documentation practices.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Excellent written, verbal, and interpersonal communication skills.
• High attention to detail and commitment to document quality and accuracy.

Preferred Qualifications

• Experience with eCTD submission structures and publishing processes.
• Experience supporting IND, IMPD, amendment, and annual report submissions.
• Familiarity with Veeva RIM or similar Regulatory Information Management Systems.
• Experience working with document management systems and regulatory archives.
• Knowledge of global regulatory submission requirements and Health Authority interactions.

Compensation

Massachusetts Pay Transparency:

• Estimated Pay Rate: $45–$55/hour (W-2)
• Final compensation will be based on experience, qualifications, and interview performance.