Regulatory Affairs – Senior Executive & Trainee Intern
Genedrift India is hiring for Senior Executive – Regulatory Affairs and Trainee Intern – Regulatory Affairs positions. These opportunities are ideal for B.Pharm and M.Pharm candidates interested in CTD Dossier Preparation, Regulatory Submissions, Compliance, Health Authority Coordination, and Global Regulatory Affairs.
📋 Job Overview
| Particulars | Details |
|---|---|
| Company | Genedrift India |
| Positions | Senior Executive & Trainee Intern |
| Location | Uttarakhand, India |
| Qualification | B.Pharm / M.Pharm |
| Experience | Freshers to 5 Years |
| Work Mode | Hybrid (Senior Executive) |
| Industry | Regulatory Affairs |
1️⃣ Senior Executive – Regulatory Affairs
Experience: 2–5 Years
Key Responsibilities
- Perform CMC review of CTD/ACTD dossiers.
- Review SmPC, PIL, and labeling documents.
- Conduct dossier gap analysis and adequacy review.
- Manage Health Authority queries and submissions.
- Coordinate pre-submission meetings.
- Ensure compliance with global regulatory guidelines.
2️⃣ Trainee Intern – Regulatory Affairs
Experience: Freshers Eligible
Key Responsibilities
- Coordinate document review and submission activities.
- Maintain SOP compliance and documentation systems.
- Track project timelines and submission status.
- Assist in document translation and finalization.
- Support regulatory documentation activities.
- Maintain internal records and compliance trackers.
🎓 Eligibility Criteria
- B.Pharm
- M.Pharm
- Good Communication Skills
- Documentation & Compliance Knowledge
- MS Office Proficiency
⭐ Preferred Skills
- Regulatory Affairs
- CTD/ACTD Dossier Preparation
- CMC Documentation
- Regulatory Compliance
- Health Authority Coordination
- Documentation Management
- Project Tracking
- Quality & Compliance Focus
🌟 Why Join Genedrift?
- Exposure to global regulatory submissions.
- Hands-on CTD and ACTD dossier experience.
- Hybrid work flexibility.
- Strong learning environment for freshers.
- Career growth in Regulatory Affairs.
- Opportunity to work with Health Authorities and compliance teams.
📈 Career Path
- Regulatory Affairs Trainee
- Regulatory Affairs Associate
- Regulatory Affairs Executive
- Senior Regulatory Affairs Executive
- Regulatory Affairs Specialist
- Regulatory Affairs Manager
- Global Regulatory Affairs Lead
📝 Resume Tips
- Highlight Regulatory Affairs coursework and projects.
- Mention CTD, ACTD, CMC, or dossier preparation exposure.
- Include internships in Regulatory Affairs or Quality Assurance.
- Showcase documentation and compliance management skills.
- Highlight communication and project coordination abilities.
- Keep your resume ATS-friendly and achievement-focused.
🎯 Interview Preparation Tips
- Understand CTD and ACTD dossier structures.
- Review CMC documentation basics.
- Learn Health Authority submission processes.
- Understand SmPC, PIL, and labeling requirements.
- Revise regulatory lifecycle management concepts.
- Review SOP compliance and document control practices.
- Research Genedrift and regulatory consulting services.
❓ Common Interview Questions
- What is Regulatory Affairs?
- What is a CTD dossier?
- What are the modules of CTD?
- What is CMC documentation?
- What is the difference between CTD and ACTD?
- What is the purpose of SmPC and PIL?
- How do you manage document version control?
- What is a Health Authority query?
- Why do you want to work in Regulatory Affairs?
- Why do you want to join Genedrift?
❓ Frequently Asked Questions (FAQ)
Q1. Are freshers eligible?
Yes, freshers can apply for the Trainee Intern role.
Q2. What experience is required for Senior Executive?
2–5 years of Regulatory Affairs experience.
Q3. Which qualifications are eligible?
B.Pharm and M.Pharm candidates.
Q4. Is hybrid work available?
Yes, the Senior Executive role is offered in hybrid mode.
Q5. What skills are preferred?
Regulatory Affairs, CTD/ACTD, CMC documentation, dossier preparation, and compliance management.
📝 How to Apply
- Review the role requirements carefully.
- Update your resume with Regulatory Affairs experience and skills.
- Highlight dossier preparation, documentation, and compliance exposure.
- Mention internships, projects, and certifications if applicable.
- Submit your application through the official link.
👉 Step-by-Step Guide: How to Apply for Healthcare & Pharma Jobs
