Are you passionate about regulatory compliance and dossier preparation? DDReg Pharma Pvt. Ltd., a leading regulatory consulting services company, is hiring a Regulatory Affairs Associate in Gurugram, Haryana. This role offers an excellent opportunity to work on global regulatory submissions, CTD/eCTD documentation, lifecycle management, and labeling compliance across EU, UK, WHO, and emerging markets.
If you have a B.Pharm or M.Pharm degree and are eager to make an impact in regulatory affairs, this could be your next career move.
📝 Key Responsibilities
As a Regulatory Affairs Associate at DDReg Pharma, you will:
- Compliance & Lifecycle Management – Prepare variation and requalification dossiers, manage product maintenance for EU, UK, WHO, and emerging markets.
- CTD/eCTD Submissions – Perform Level-1 review of CTD/eCTD sequences for DKT, FHI, and BO product submissions.
- Query Handling – Draft and review responses to regulatory authority queries with accuracy and clarity.
- Electronic Publishing – Prepare functional files (hyperlinking, bookmarking, formatting, redactions) to ensure submission accuracy.
- Artwork & Labeling Review – Validate annotated artwork and labeling texts for regulatory consistency.
- Project Tracking – Maintain trackers, history logs, planners, and query records for client and internal reporting.
- Collaboration – Ensure clear communication with internal teams and external clients.
🎓 Educational Qualifications
- B.Pharm or M.Pharm (mandatory)
🌟 Desired Skills
- Strong communication and interpersonal skills
- Time management & multitasking abilities
- Analytical thinking & problem-solving
- Adaptability and teamwork
💼 Benefits of Joining DDReg Pharma
- Work on international regulatory submissions (EU, UK, WHO, emerging markets)
- Exposure to CTD/eCTD lifecycle management
- Collaborative team environment
- Career growth in a leading regulatory consulting services firm