Encore Group is hiring for Officer – Regulatory Affairs & Jr. Executive / Executive at its Head Office – Fort, Mumbai (Ballard Estate). This Regulatory Affairs job in Mumbai is ideal for M.Pharm/B.Pharm professionals with at least 2 years of experience in dossier preparation, CTD/ACTD/eCTD submissions, and ROW market regulatory compliance.
If you are seeking a Regulatory Affairs Officer job in Mumbai with exposure to international markets, post-approval variations, and regulatory database management, this opportunity offers strong domain growth.
📌 Job Overview
- Position: Officer – Regulatory Affairs / Jr. Executive / Executive
- Department: Regulatory Affairs
- Location: Head Office – Fort, Mumbai (Ballard Estate)
- Qualification: M.Pharm / B.Pharm
- Experience: Minimum 2 years in Regulatory Affairs
- Industry: Pharmaceutical – ROW Market Regulatory
🔎 Key Responsibilities
The selected candidate will be responsible for:
1️⃣ Dossier Preparation & Submissions
- Preparation of CTD / ACTD / eCTD dossiers
- Country-specific format submissions for ROW markets
- Ensuring error-free and timely regulatory submissions
2️⃣ Regulatory Query Management
- Evaluate and respond to health authority queries
- Address customer-specific regulatory requirements
3️⃣ Post-Approval Variations
- Filing post-approval variations as per regulatory guidelines
- Compliance with country-specific variation frameworks
4️⃣ Technical Document Review
Review and align site documentation with dossier requirements:
- Process Validation
- AMV
- Stability Data
- PDR
- CDP
5️⃣ Cross-Functional Coordination
- Coordinate with HO, Plant, QA, and R&D teams
- Collect documents and samples for registration purposes
6️⃣ Artwork Development
- Development and review of new artworks
- Ensure compliance for registration and commercial use
7️⃣ Regulatory Database Management
- Maintain and update regulatory database
- Track manufacturing, quality documents, registrations, and RLD samples
8️⃣ Administrative Documentation
- Application and review of:
- Product Permissions
- COPPs
- FSCs
🎓 Qualifications Required
- M.Pharm or B.Pharm
- Minimum 2 years of experience in Regulatory Affairs
- Hands-on experience with CTD/eCTD submissions
- Knowledge of ROW market regulations
- Strong documentation and coordination skills
💼 Why Apply for This Regulatory Affairs Job in Mumbai?
- Exposure to international regulatory markets
- Experience in end-to-end dossier lifecycle
- Hands-on role in post-approval variations
- Cross-functional regulatory coordination
- Growth opportunity in pharmaceutical regulatory affairs
This Regulatory Affairs Officer role in Mumbai is well-suited for professionals aiming to build expertise in ROW regulatory submissions, CTD dossier preparation, and regulatory compliance management.
📧 How to Apply
Interested candidates can share their updated resume to:
