Industry: Pharmaceutical

Experience: 5–7 Years

Qualification: B.Pharm / M.Pharm

Position: Deputy Manager – International & Domestic Regulatory Affairs

Reporting To: QA Head

Salary: ₹3–7 LPA, based on experience and suitability

Location: Road No. 7, Banjara Hills, Hyderabad, Telangana

We are looking for an experienced Regulatory Affairs professional to manage regulatory submissions, documentation, product registrations, and compliance activities.

Key Responsibilities

- Prepare, review, and submit regulatory dossiers, applications, and supporting documents.
- Manage submissions, approvals, renewals, variations, and amendments.
- Ensure compliance with pharmaceutical regulatory requirements and guidelines.
- Coordinate with QA, QC, Production, R&D;, and other departments for regulatory documentation.
- Handle regulatory queries, maintain approval records, monitor regulatory updates, and support inspections.

Candidate Requirements

•Robust experience in international pharmaceutical regulatory affairs.





•Hands-on experience in product registration across African, ASEAN, CIS, and Middle Eastern markets.

•Expertise in CTD/eCTD and ACTD dossier preparation and submission.

•Experience in WHO-GMP compliance and international regulatory guidelines.

•Knowledge of product registration, renewals, variations, and lifecycle management.

•Ability to independently manage regulatory submissions and respond to regulatory queries.

•Experience coordinating with international agents, consultants, and regulatory authorities.

•Strong leadership, communication, and team management skills.

Key Skills: Regulatory Submissions | Dossier Preparation | GMP | Regulatory Compliance | Product Registration | Documentation | Cross-functional Coordination

Preferred: Candidates with experience in export-oriented pharmaceutical formulation companies and international product registration projects.

📌 Regulatory Affairs – Assistant/Deputy Manager (Hyderabad)
🏢 Sparsha Pharma International
📍 Hyderabad