Regulatory Affairs Intern

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