BGBx
Company:
https://www.linkedin.com/company/bgbx
Seniority: Not Applicable
Industries: Advertising Services
Job details:
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 deadlines and communicate status updates to internal stakeholders.
- Ensure compliance with company policies, client procedures, and applicable regulatory guidelines.
Preferred 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.
- Experience with regulatory review platforms such as Veeva PromoMats, Zinc, Aprimo, or similar systems is a plus.
- Strong attention to detail and ability to manage multiple projects simultaneously.
- Excellent organizational, communication, and follow-up skills.
- Ability to work collaboratively across teams and manage timelines in a deadline-driven environment.
- Familiarity with pharmaceutical, biotech, or healthcare promotional review processes is preferred.
- Proficiency with Microsoft Office, Adobe Acrobat, and document management tools.
Preferred Skills
- Understanding of MLR review processes and promotional material submission requirements.
- Experience supporting pharmaceutical or healthcare agency clients.
- Strong version-control and document-management skills.
- Ability to identify inconsistencies, missing information, and process gaps.
- Comfort working in fast-paced, highly regulated environments.
Success Measures
- Accurate and timely submission of regulatory materials.
- Strong documentation and tracking discipline.
- Effective communication with internal and external stakeholders.
- Minimal submission errors or rework.
- Consistent adherence to process, compliance, and client-specific requirements.
Salary Range
INR 850,000 - 1,100,000
8.5 - 11 LPA
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