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

Work arrangement
No