RBGM Medical Sales Express Inc. is looking for a detail-oriented and organized Regulatory Assistant to join our Regulatory Department. The successful candidate will provide administrative and regulatory support, particularly in maintaining compliance documentation and assisting with regulatory submissions for third-party principal products.
Key responsibilities
- Assist in the documentation process for product codes initiated by Sales, Marketing, and Management.
- Coordinate with third-party principals to obtain required regulatory documents and follow up on pending requirements.
- Track and document responses from principals and ensure submission requirements are complete.
- Prepare regulatory submission documents under the guidance of the Regulatory Supervisor.
- Maintain an organized database of regulatory documents and submission records.
- Ensure documents are accurate, complete, and properly organized for easy retrieval.
- Perform other regulatory-related duties as assigned.
About You
- Bachelor's degree in Pharmacy.
- Must be a Licensed Pharmacist.
- At least 6 months of experience in coordination or document processing is preferred.
- Knowledge of FDA policies, procedures, and regulatory requirements.
- Familiarity with regulatory submission processes and documentation.
- Strong organizational and time-management skills.
- Excellent written and verbal communication skills.
- Highly detail-oriented and accurate when handling documents.
- Proactive, resourceful, and able to work independently and as part of a team.
- Demonstrates a high level of integrity and professionalism.
