Regulatory Operations Associate

Overview

The Regulatory Operations Associate supports the preparation, submission, tracking, and maintenance of promotional and regulatory materials to ensure compliance with internal processes, client requirements, and applicable regulatory standards, working cross-functionally to support efficient MLR review workflows within Veeva PromoMats.

What you'll do

• Support the preparation, quality control, submission, and maintenance of promotional and regulatory materials within Veeva PromoMats.
• Perform tagging, linking, annotation, and reference management for promotional materials to support MLR review and approval processes.
• Perform reference quality checks prior to submission to confirm supporting reference documents are the correct approved versions, contain appropriate reference identifiers, and are approved for use within Veeva PromoMats.
• Maintain and update client reference trackers/master reference lists to support accurate tagging, linking, and annotation workflows during promotional material submissions.
• Upload submission packages, supporting documentation, references, and metadata into Veeva PromoMats.
• Assist with reference uploads and supporting documentation management within Veeva PromoMats as needed in partnership with Account teams.
• Conduct quality checks to ensure annotations, claims, references, hyperlinks, version control, and required submission components are accurate, compliant, and aligned with approved supporting documentation.
• Track submission status, review comments, approvals, and required follow-ups throughout the review lifecycle.
• Maintain organized records of submissions, approval documentation, correspondence, and archived materials.
• Collaborate with cross-functional teams to ensure materials align with client requirements, submission standards, and project timelines.
• Identify and help resolve submission issues, missing documentation, linking discrepancies, or system-related errors.
• Support the development and maintenance of standard operating procedures (SOPs), templates, trackers, and regulatory operations workflows.
• Monitor deadlines and communicate submission status updates to internal stakeholders.
• Ensure adherence to company policies, client procedures, and applicable regulatory and promotional review guidelines.

What you'll need

• Bachelor's degree preferred, ideally in life sciences, communications, healthcare, business, or a related field.
• 1–3 years of experience in regulatory operations, promotional review, medical communications, pharmaceutical advertising, healthcare marketing, or a related environment preferred.
• Hands-on experience with Veeva PromoMats strongly preferred.
• Strong attention to detail and ability to manage multiple projects simultaneously in a deadline-driven environment.
• Excellent organizational, communication, and follow-up skills.
• Ability to collaborate effectively across cross-functional teams.
• Proficiency with Microsoft Office, Adobe Acrobat, and document management systems.

Nice to have

• Experience with promotional material annotation, tagging, linking, and reference management.
• Experience performing reference verification, approval checks, and master reference management within Veeva PromoMats.
• Familiarity with pharmaceutical, biotech, or healthcare promotional review processes.
• Understanding of MLR review processes and promotional material submission requirements.
• Experience supporting pharmaceutical or healthcare agency clients.
• Strong document management, version control, and quality control skills.
• Experience reviewing annotated claims and supporting references for accuracy and completeness.
• Understanding of tagging/linking workflows and reference-based annotation processes for promotional review submissions.
• Ability to identify inconsistencies, missing information, and process gaps.
• Comfort working in fast-paced, highly regulated environments.

Details

• Working hours: 9:00am - 5:30pm ET, Monday through Friday.
• Salary range: INR 850,000 - 1,100,000 (8.5 - 11 LPA).