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Position – RA

Job Summary

We are seeking experience of 15 to 22 years

Qualification: M.Pharma

Responsibilities are as follows

JD for RA role

- Assist in the Preparation, review of specification, method of analysis of Raw

Material, Packing material and finished product (API).

- Assist in the Preparation, review of specification, method of analysis of Raw

Material, Packing material and finished product (DC Granulation).

- To prepare technical package for DC Granules.
- To assist for preparation and review QMS granulation documents.
- Maintain organized and up-to-date regulatory files and documentation.
- Support for the preparation of response to queries and information requests from regulatory authorities.
- Preparation of documents for the submission to regulatory authorities associated with various regulatory requirements, authoring/ or coordinating RA activities for recent registration / licenses,



post approval changes.
- Provide regulatory input to cross-functional teams to ensure alignment with regulatory requirement.
- To assist quality assurance department to address regulatory compliance and implement corrective actions as needed.
- Ensure compliance with relevant regulatory requirements, standards, and guidelines.
- To assist cross-functional teams, including Research and Development, Quality assurance, and Manufacturing, to ensure regulatory requirements are integrated into development plans.
- Stay current on industry best practices and regulatory trends.
- To review the compliances ensure the GMP implementation in the organization.
- To assist for the preparation of compliances report.

📌 Position – RA (Vadodara)
🏢 Acumen360 Consulting u0026 HR Solutions
📍 Vadodara