Position – RA

Job Description:

Position – RA
Job Summary:
We are seeking experience of 15 to 22 years
Qualification: M.Pharma
Responsibilities are as follows:
JD for RA role

1. Assist in the Preparation, review of specification, method of analysis of Raw
Material, Packing material and finished product (API).
2. Assist in the Preparation, review of specification, method of analysis of Raw
Material, Packing material and finished product (DC Granulation).
3. To prepare technical package for DC Granules.
4. To assist for preparation and review QMS granulation documents.
5. Maintain organized and up-to-date regulatory files and documentation.
6. Support for the preparation of response to queries and information requests from
regulatory authorities.
7. Preparation of documents for the submission to regulatory authorities associated
with various regulatory requirements, authoring/ or coordinating RA activities
for new registration / licenses, post approval changes.
8. Provide regulatory input to cross-functional teams to ensure alignment with
regulatory requirement.
9. To assist quality assurance department to address regulatory compliance and
implement corrective actions as needed.
10. Ensure compliance with relevant regulatory requirements, standards, and
guidelines.
11. To assist cross-functional teams, including Research and Development, Quality
assurance, and Manufacturing, to ensure regulatory requirements are integrated
into development plans.
12. Stay current on industry best practices and regulatory trends.
13. To review the compliances ensure the GMP implementation in the organization.
14. To assist for the preparation of compliances report.