Key Responsibilities:
✔ Deficiency Management for the US Market – Handling ANDA submissions and responses.
✔ Compile & review ANDAs and their Deficiency responses.
✔ Work on IND / 505(b)(2) / Innovations projects for the US market.
✔ Strong analytical & formulation understanding of various dosage forms.
✔ Sound knowledge of Regulatory Science, ICH guidelines, and GDUFA.
✔ Support cross-functional teams to ensure timely and high-quality submissions of NDA/ANDA/Deficiency responses.
Preferred Candidate Profile:
✅ 2+ years of experience in IRA (US Market) – Regulatory Affairs, ANDA, USFDA submissions.
✅ Strong regulatory writing, problem-solving, and communication skills.
✅ Educational Qualification: B.Pharma / M.Pharma / M.Sc in relevant fields.
✅ Must be willing to work from Ahmedabad office.
About Zydus Lifesciences
Zydus Lifesciences is a global innovative lifesciences company committed to empowering people with healthier lives. With a workforce of 23,000+ employees, Zydus operates across India, the US, and Brazil, focusing on discovering, developing, and manufacturing high-quality healthcare solutions.
🔹 Mission: To unlock new possibilities in life sciences through groundbreaking healthcare solutions.
🔹 Vision: To become a global leader in transforming lives via cutting-edge discoveries.
📌 Location: Vaishnodevi Circle, Ahmedabad (Work from Office)
💰 Salary: ₹4 – 6.5 LPA
📅 Experience Required: 2-5 years
📝 Openings: 1
How to Apply?
You Can Send Resume To Recruiter if You Have Experience alpesh.b.solanki@zyduslife.com
