Regulatory Affairs Intern (Mumbai)

Regulatory Affairs Intern (Mumbai)

08 Oct
|
Meliorate Health
|
Mumbai

08 Oct

Meliorate Health

Mumbai

We Meliorate Health would like to introduce ourselves as a registered Healthcare product manufacturer in Mumbai, India. Our products are, pharmaceutical formulation, food supplementary products & herbal products. We aim to provide one stop service center for all our global partners for hospital & medical needs. We have a nutraceutical manufacturing facility at Ahmednagar, Maharashtra. To know more about us kindly go through our website www.melioratehealth.com . We Meliorate Health are pleased to inform you that our company is offering Regulatory Affairs Intern Position to B. Pharm/M. Pharm candidates. Please read the JD mentioned below for more details about the role.

Designation: Regulatory Affairs Intern
Qualification: B. Pharm / M. Pharm (Completed)
Department: Regulatory Affairs
Location: Goregaon East, Mumbai
Stipend: Traveling Allowances

Job Responsibilities:

1) Dossier Support:

- Assist in preparation and compilation of dossiers (ACTD, CTD, eCTD) as per country-specific guidelines.
- Support in reviewing documents for completeness and accuracy.

2) Query Assistance:

- Assist in drafting responses to regulatory queries under guidance of seniors.
- Maintain records of queries and responses for tracking purposes.

3) FDA Documentation Support:

- Provide assistance in documentation related to product approvals, COPPs, FSCs,



and tender submissions.
- Coordinate with internal teams for required documents.

4) Cross-functional Coordination:

- Coordinate with plant teams for arranging samples and required documents.
- Work with R&D; and QA teams for collecting MFR, BMR, and related documents.
- Support coordination with Marketing and Export teams for registration activities.

5) Documentation & Data Management:

- Maintain proper filing and organization of dossiers and regulatory documents as per company policies.
- Assist in maintaining databases and trackers for regulatory submissions.

6) Artwork & Sample Coordination:

- Assist in coordination for artwork development (labels, cartons, leaflets) with design team.
- Support in sample handling, printing, and dispatch activities.

7) General Support Activities:

- Assist in preparation of documents such as MSDS, invoices, covering letters, and indemnity letters.
- Support in notarization, legalization, and apostille processes under supervision.
- Conduct basic research (data surfing) related to clinical/non-clinical information for dossiers.
- Work collaboratively with the Regulatory Affairs team on day-to-day activities.

Pay: ₹2,500.00 - ₹3,000.00 per month

Work Location: In person

📌 Regulatory Affairs Intern (Mumbai)
🏢 Meliorate Health
📍 Mumbai

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