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Looking for a Regulatory Affairs Executive job in Mumbai? Akums Drugs & Pharmaceuticals Ltd is hiring experienced professionals for Executive / Sr. Executive – Regulatory Affairs roles in Andheri East, Mumbai.
This opportunity is ideal for candidates with 3–6 years of regulatory affairs experience, especially in dossier preparation, CTD/ACTD formats, and ROW market submissions. If you have hands-on experience in regulatory compliance, MOH query handling, and lifecycle management, this role offers strong career growth in the pharmaceutical regulatory domain.
📌 Job Details
- Position: Executive / Sr. Executive – Regulatory Affairs
- Company: Akums Drugs & Pharmaceuticals Ltd
- Location: Andheri East, Mumbai
- Experience: 3–6 Years
- Qualification: B.Pharm / M.Pharm
- Salary: ₹4 – ₹5.5 LPA (Expected Range)
- Job Type: Full-Time
🧪 Key Responsibilities – Regulatory Affairs Executive
1. Dossier Preparation & Submission
- Prepare, compile, and review CTD / ACTD dossiers for ROW markets
- Ensure completeness and compliance of regulatory documents
- Handle country-specific submission requirements
2. Query Handling & Lifecycle Management
- Respond to MOH queries and deficiency letters within timelines
- Manage post-approval submissions (variations, renewals, retentions)
- Coordinate lifecycle activities as per regulatory schedules
3. Cross-functional Coordination
- Work with QA, QC, Production, and R&D teams for documentation
- Ensure artwork and labeling compliance as per registered dossiers
- Maintain regulatory submission trackers and archives
🎯 Required Skills & Expertise
Technical Skills
- Strong knowledge of ICH Guidelines
- Hands-on experience in CTD & ACTD formats
- Experience in ROW market dossier submission
- Understanding of DMF, COA, Stability Data, GMP documentation
Functional Skills
- Expertise in handling regulatory authority queries (MOH)
- Strong coordination and documentation skills
- Experience in regulatory database management
🎓 Eligibility Criteria
- B.Pharm / M.Pharm (Mandatory)
- 3–6 years experience in Regulatory Affairs
- Experience in international regulatory submissions (ROW markets) preferred
💼 Why Join Akums?
- Work with one of India’s leading pharmaceutical manufacturing companies
- Exposure to global regulatory submissions (ROW markets)
- Strong career growth in Regulatory Affairs & Compliance
- Opportunity to work with cross-functional pharma teams
📥 How to Apply
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