Company : Sain Medicaments Pvt Ltd, Uppal, Hyderabad, Telangana.

Position: Senior Executive – Regulatory Affairs

Industry: Pharmaceutical Formulations

Experience: 5–6 Years

Location: Hyderabad

Department: Regulatory Affairs

? Key Requirement: Hands-on experience in ROW / Emerging Markets

We are looking for an experienced Regulatory Affairs qualified with strong exposure to pharmaceutical formulations and regulatory submissions across Asia, Africa, LATAM, CIS, and Middle East markets .

? Key Responsibilities

• Manage end-to-end regulatory activities for ROW / Emerging Markets

- Prepare, compile, review and submit regulatory dossiers for pharmaceutical formulations

• Handle new product registrations, renewals, variations, re-registrations and post-approval changes

• Prepare and review dossiers in CTD / country-specific formats , as applicable

- Coordinate responses to regulatory queries, deficiencies and clarification requests

• Liaise with regulatory authorities, local agents, consultants and overseas business partners

- Review country-specific regulatory requirements and ensure dossier compliance

• Coordinate with QA, QC, R&D;, Production, Packaging,



Supply Chain and Business Development teams for regulatory documentation

- Manage regulatory lifecycle activities and ensure timely submissions/approvals
- Track registration status, renewals, variations and regulatory commitments

• Monitor regulatory updates and provide regulatory intelligence for assigned markets

- Support business development and new market expansion by providing regulatory inputs and feasibility assessments

? Preferred Market Exposure

? Asia

? Africa

? LATAM – Latin America

? CIS Countries

?️ Middle East / GCC

? Candidate Profile

✔ 5–6 years of experience in Regulatory Affairs – Pharmaceutical Formulations

✔ Strong hands-on experience in ROW / Emerging Market registrations

✔ Good understanding of CTD and pharmaceutical regulatory documentation

✔ Experience in registrations, renewals, variations and post-approval activities

✔ Strong regulatory dossier preparation and review skills

✔ Excellent coordination, communication and follow-up skills

✔ Ability to independently manage multiple products/markets

? Qualification

B.Pharm / M.Pharm / Pharm.D

? Location: Hyderabad

📌 Senior Regulatory Affairs Specialist (Uppal)
🏢 SAIN MEDICAMENTS
📍 Uppal