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If you are a pharmaceutical professional looking to build a strong career in Drug Regulatory Affairs, this opportunity at DDReg Pharma, Gurgaon is an excellent fit. The role is ideal for candidates with 2+ years of hands-on experience in CTD/eCTD submissions, dossier preparation, and regulatory lifecycle management for GHC/KSA markets.
DDReg Pharma is known for its robust global regulatory support services and offers an excellent learning environment for ambitious regulatory professionals.
🔍 Job Overview
- Position: Associate – Drug Regulatory Affairs (GHC/KSA)
- Company: DDReg Pharma
- Location: Gurgaon
- Experience: 2+ Years
- Qualification: B.Pharm / M.Pharm
- Employment Type: Full-Time
📝 Key Responsibilities
1. Regulatory Compliance & Lifecycle Management
- Prepare variation and requalification dossiers.
- Maintain regulatory product updates for GHC/KSA authorities.
2. CTD/eCTD Review & Publishing
- Perform Level-1 review of CTD/eCTD sequences.
- Ensure submission accuracy, compliance, and formatting standards.
- Manage publishing tasks including:
- Hyperlinking
- Bookmarking
- Redaction
- Technical formatting
3. Query Management
- Draft regulatory responses for health authority queries.
- Ensure responses are compliant, clear, and timely.
4. Artwork & Labelling Review
- Review annotated artworks and comparative labels.
- Ensure regulatory consistency and accuracy.
5. Documentation & Project Tracking
- Maintain:
- Product history
- Submission trackers
- Task planners
- Query logs
- Provide timely updates for internal and client reporting.
6. Stakeholder Coordination
- Collaborate with internal teams and global clients.
- Ensure seamless communication and professional documentation support.
🎓 Educational Qualifications
- B.Pharm / M.Pharm
- Strong understanding of CTD/eCTD format, GHC regulatory requirements, and dossier preparation.
💼 Why Join DDReg Pharma?
- Contribute to global regulatory submissions.
- Gain exposure to GHC/KSA health authority guidelines.
- Opportunities for continuous learning and professional growth.
- Collaborative work culture with supportive teams.
📌 How to Apply
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