Regulatory Operations Associate (Mumbai)

Regulatory Operations Associate (Mumbai)

16 Aug
|
BGBx
|
Mumbai

16 Aug

BGBx

Mumbai

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 regulatory materials to ensure compliance with internal processes, client requirements, and applicable regulatory standards. This role works cross-functionally with Regulatory Affairs, Medical, Legal, Creative, Account, Project Management, and external partners to help manage submission workflows, maintain documentation, and ensure materials are accurate, complete, and submission-ready.

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

Responsibilities include:
- Support the preparation, formatting,



quality control, and submission of regulatory materials.
- Manage submission documentation, metadata, references, and supporting files.
- Track submission status, approvals, comments, and required follow-ups.
- Maintain organized records of regulatory submissions, correspondence, and approval documentation.
- Partner with cross-functional teams to ensure materials meet submission requirements and timelines.
- Assist with uploads and routing in regulatory review systems such as Veeva PromoMats, Zinc, Aprimo, or similar platforms.
- Perform quality checks to confirm version control, annotations, references, claims, links, and required components are accurate.
- Help resolve submission issues, missing documentation, or system-related discrepancies.
- Support the development and maintenance of standard operating procedures, trackers, templates, and regulatory operations workflows.
- Monitor deadli

📌 Regulatory Operations Associate (Mumbai)
🏢 BGBx
📍 Mumbai

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