DDReg Pharma, a leading global regulatory consulting firm, is hiring an Associate – Regulatory Affairs for its Gurgaon office. This full-time position is ideal for pharmacy graduates passionate about regulatory compliance, CTD/eCTD documentation, and global submissions across the EU, UK, WHO, and emerging markets.
If you have a detail-oriented mindset and thrive in a fast-paced pharmaceutical environment, this opportunity can take your regulatory career to the next level.
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Key Responsibilities
As an Associate – Regulatory Affairs, your responsibilities will include:
- Regulatory Compliance & Lifecycle Management:
Prepare variation and requalification dossiers. Support maintenance submissions for EU, UK, WHO, and ROW markets. - CTD/eCTD Sequence Review:
Conduct Level-1 reviews of DKT, FHI, and BO product submissions. Ensure adherence to submission standards and timelines. - Query Handling & Documentation:
Draft and review regulatory authority responses. Maintain clarity and compliance across communications. - Electronic Publishing Support:
Manage hyperlinking, bookmarking, redactions, and formatting for submission-ready dossiers. - Artwork & Labeling Review:
Verify annotated artwork and labeling texts for accuracy and consistency. - Project Tracking & Reporting:
Maintain trackers, task planners, and query logs for audit readiness and client transparency. - Collaboration:
Liaise with cross-functional teams and clients to ensure smooth workflow and timely submission delivery.
Educational Qualifications
- B.Pharm or M.Pharm from a recognized university
- 1–3 years of experience in Regulatory Affairs preferred
Soft Skills Required
- Strong communication and interpersonal skills
- Excellent time management and multitasking ability
- Analytical mindset and collaborative approach
- Adaptability with a proactive attitude
Benefits
- Competitive salary package (₹3.5–6 LPA depending on experience)
- Exposure to global regulatory frameworks
- Professional development through cross-market submissions
- Collaborative and growth-driven work culture
How to Apply
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