Are you a skilled Regulatory Affairs professional looking for a dynamic role in the pharmaceutical industry? DDReg Pharma is seeking a detail-oriented and proactive Regulatory Associate to join their team in Gurgaon. This is a fantastic full-time opportunity to work on global regulatory submissions and manage product lifecycles for diverse markets. Read on to discover the complete job description, required skills, and how to apply.
Job Description: Regulatory Associate
Job Purpose:
We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for the EU, UK, WHO, and other emerging markets.
Key Responsibilities:
- Compliance & Lifecycle Management: Prepare variation and requalification dossiers. Manage regulatory product maintenance across EU, UK, WHO, and other emerging markets.
- eCTD/CTD Sequence Review: Perform Level-1 review of CTD/eCTD sequences for various product submissions. Ensure submission quality and compliance with productivity and regulatory standards.
- Query Handling & Documentation: Draft and review responses to regulatory authorities. Ensure clarity, regulatory alignment, and timely submission.
- Functional File Preparation: Handle electronic publishing tasks including hyperlinking, bookmarking, redactions, and formatting to ensure technical accuracy.
- Artwork & Labeling Review: Review annotated artwork and comparative labeling texts for accuracy, consistency, and regulatory compliance.
- Project Tracking & Documentation: Maintain trackers, task planners, and product history logs for accurate internal and client reporting.
- Team Collaboration & Communication: Facilitate smooth communication with internal stakeholders and external clients.
Educational Qualifications:
- B.Pharm / M.Pharm
Required Soft Skills:
- Strong communication and interpersonal skills.
- Excellent time management and multitasking abilities.
- Analytical thinking and a collaborative mindset.
- A positive and adaptable attitude.
About DDReg Pharma
DDReg Pharma is a renowned name in the global pharmaceutical regulatory landscape. The company specializes in providing end-to-end regulatory solutions, helping pharmaceutical companies navigate the complex process of getting products to market. With a focus on quality, compliance, and efficiency, DDReg Pharma works on a wide range of pharmaceutical products across international markets, including Europe, the UK, and emerging regions. Joining their team means becoming part of a dedicated group of experts committed to excellence in regulatory affairs.
