– Executive / Regulatory Affairs

Position: Executive – Regulatory Affairs

Department: Regulatory Affairs

Industry: Pharmaceutical Formulations

Experience: 2–3 Years

Location: Hyderabad

Job Summary

We are looking for a Regulatory Affairs Executive with 2–3 years of experience in the pharmaceutical industry , preferably in formulations, to support regulatory submissions, documentation, product registrations, renewals, variations and regulatory compliance activities for domestic and international markets.

Key Roles & Responsibilities

1. Regulatory Documentation

- Prepare, compile and review regulatory documents required for pharmaceutical product registrations and submissions .
- Support preparation of dossiers in CTD/eCTD and country-specific formats , as applicable.
- Compile documents from QA, QC, R&D;, Production, Packaging and other relevant departments.
- Ensure regulatory documents are complete, accurate and submitted within defined timelines.

2. Product Registration & Submissions

- Assist in preparation and submission of:
- New product registrations
- Renewals
- Variations / post-approval changes
- Re-registrations
- Amendments and other regulatory submissions
- Coordinate with relevant internal teams to obtain required technical and quality documents.
- Maintain submission trackers and monitor regulatory timelines.

3. Regulatory Authority Queries

- Coordinate responses to regulatory authority queries/deficiencies .
- Collect supporting information and documents from QA, QC, R&D;, Manufacturing and other departments.
- Assist in preparing responses and ensuring timely submission of responses to regulatory authorities.

4. International / ROW Regulatory Activities





- Support regulatory activities for emerging/ROW markets , as applicable.
- Assist with country-specific registration requirements and documentation.
- Coordinate with local agents, consultants and business partners for regulatory submissions and follow-ups.
- Maintain awareness of country-specific regulatory requirements.

5. Regulatory Compliance

- Monitor applicable regulatory requirements and communicate relevant changes to concerned departments.
- Ensure regulatory submissions and documentation are aligned with applicable guidelines and company procedures.
- Support maintenance of approved product information and regulatory records.

6. Post-Approval Activities

- Support regulatory assessment and documentation for:
- Manufacturing site changes
- Formulation changes
- Packaging changes
- Specifications/test method changes
- Labeling/artwork changes
- Other post-approval variations
- Coordinate with cross-functional teams for implementation of approved changes.

7. Regulatory Tracking & Documentation Control

- Maintain regulatory databases, trackers and submission records.
- Track submission status, approvals, renewals, commitments and pending activities.
- Maintain proper filing and archival of regulatory documents.
- Ensure regulatory documents are readily available for audits and inspections.

8.



Cross-Functional Coordination

- Work closely with QA, QC, R&D;, Production, Packaging, Supply Chain and Business Development teams.
- Follow up with concerned departments for timely completion of regulatory documentation.
- Participate in cross-functional meetings related to regulatory submissions and product development.

9. Audit & Inspection Support

- Assist in providing regulatory documentation and information during internal, customer and regulatory audits/inspections .
- Ensure regulatory records are maintained in an organized and compliant manner.

Candidate Profile
- B.Pharm / M.Pharm / Pharm.D or equivalent qualification.
- 2–3 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.
- Experience in pharmaceutical formulations will be preferred.
- Exposure to CTD/eCTD dossier preparation and regulatory submissions .
- Knowledge of product registrations, renewals, variations and regulatory documentation.
- Exposure to ROW/emerging markets such as Asia, Africa, LATAM, CIS or Middle East will be an advantage.
- Good written and verbal communication skills.
- Solid documentation, coordination and follow-up skills.
- Good knowledge of MS Office, particularly Word and Excel .

Key Skills Regulatory Affairs | Pharmaceutical Formulations | CTD/eCTD | Dossier Compilation | Product Registration | Renewals | Variations | Regulatory Submissions | Deficiency Responses | ROW Markets | Regulatory Compliance | Documentation | Regulatory Tracking

Preferred Designation

Executive – Regulatory Affairs

Experience: 2–3 Years

Location: Hyderabad

Industry: Pharmaceutical Formulations

📌 Regulatory Affairs Executive (Uppal)
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