Regulatory Affairs Executive

Job Description – 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.
• Strong 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