Drug Regulatory Affair jobs

BGB Group

Regulatory Operations Associate

Our Agency

BGB Group is a healthcare communications agency that offers a wide range of services, including traditional pharmaceutical advertising, promotional medical education, payer marketing, and consulting services. Known for excellence and professionalism, we're hired as strategic and creative partners by our biopharmaceutical clients to drive category/brand awareness and growth.

Position 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. This role partners cross-functionally with Regulatory Affairs, Medical, Legal, Creative, Account, and Project Management teams to support efficient MLR review workflows, maintain submission documentation, and ensure materials are accurate, complete, and submission-ready within Veeva PromoMats.

This position follows the working hours of 9:00am - 5:30pm ET Monday through Friday.

Key Responsibilities:

• 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.

Qualifications

• 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.
• Experience with promotional material annotation, tagging, linking, and reference management is preferred.
• Experience performing reference verification, approval checks, and master reference management within Veeva PromoMats is 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.
• Familiarity with pharmaceutical, biotech, or healthcare promotional review processes is preferred.
• Proficiency with Microsoft Office, Adobe Acrobat, and document management systems.

Preferred Skills

• 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.

Success Measures

• Accurate and timely submission of promotional and regulatory materials.
• High-quality tagging, linking, annotation, and documentation management.
• Accurate maintenance of approved reference documentation and master reference lists.
• Minimal submission errors, broken links, annotation discrepancies, or reference-related issues.
• Effective communication and collaboration with internal stakeholders.
• Consistent adherence to compliance standards, client procedures, and submission timelines.

Salary Range:

INR 850,000 - 1,100,000

8.5 - 11 LPA