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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