Sangharsh Lifecare Pvt Ltd, a rapidly growing global pharmaceutical company, is looking for a Regulatory Affairs Executive to join their dynamic team in Ahmedabad. If you’re detail-oriented, motivated, and passionate about regulatory affairs, this could be the perfect opportunity for you! 💼✨
About the Role 📝
As a Regulatory Affairs Executive, you will play a key role in ensuring compliance with regulatory requirements for pharmaceutical products. Your responsibilities include:
📌 Product Lifecycle Management: Handling CDP, BE studies, and BCS classification throughout the product lifecycle.
📌 Dossier Preparation: Preparing and submitting dossiers in CTD and ACTD formats for regulatory approvals.
📌 Regulatory Submissions: Managing AMV, DMF, and other regulatory submissions.
📌 Bio-Waiver Applications: Preparing and submitting bio-waiver documentation.
Requirements 📚
✔ Qualification: B.Pharm or M.Pharm
✔ Experience: Minimum 3 years in dossier preparation (CTD/ACTD) with exposure to ROW and EU markets
✔ Expertise In: CDP, BE studies, BCS classification, bio-waiver
✔ Skills: Excellent written and verbal communication
What You Can Expect 🌈
🌟 Career Growth: Opportunities to advance in a global pharmaceutical environment
🤝 Collaborative Culture: Work with skilled and experienced regulatory professionals
💰 Attractive Salary: Competitive compensation and benefits
How to Apply 📧
Interested candidates can send their updated resume to vishal@sangharsh.biz
We look forward to connecting with you! 📲
Tips for Regulatory Affairs Professionals 📚
- 📖 Strengthen your understanding of CDP, BE studies, BCS classification, and bio-waiver.
- ✍️ Improve written and verbal communication skills.
- 🔍 Stay updated with changing regulatory guidelines and global market requirements.
Why Choose Sangharsh Lifecare Pvt Ltd? 🤔
🏆 A leading, fast-growing pharmaceutical company delivering high-quality products
🎓 Strong focus on learning, development, and professional growth
🤝 Supportive and collaborative work culture
