WALK-IN INTERVIEW | Biosimilar Regulatory Affairs (SRE / Asst. Manager) 🚨
- 📅 23rd August 2026, Sunday | 8:30 AM – 4:00 PM
- 🏨 Venue: Hotel Enrise (By Sayaji), Survey No. 80/1, Phase-2, Marunji Road, Vinode Nagar, Wakad, Hinjewadi, Pimpri-Chinchwad, Pune, Maharashtra
At Ipca Biomanufacturing, We’re hiring for Biosimilar Regulatory Affairs professionals to support submissions for developed markets (US FDA, EMA, MHRA, Health Canada, TGA, etc.) and semi-regulated markets.
📌 Job Location: Mumbai (Maharashtra) or Pithampur (Madhya Pradesh)
✅ What We’re Looking For
• 6–10 years of core biosimilar regulatory submission experience (mandatory)
• Strong expertise in CMC writing and dossier preparation
• Proven experience working with cross-functional teams (CFT) and managing global/domestic submissions
• Excellent communication and stakeholder-management skills
🎯 Key Responsibilities
• Prepare and review CMC sections and regulatory submission documents
• Coordinate with R&D, QA, and Manufacturing for dossier readiness
• Lead submission planning and regulatory interactions for markets worldwide
• Ensure compliance with regional regulatory requirements and timelines
⚠️ Only candidates with biosimilar regulatory experience will be considered.
📄 Documents to Carry
Passport-size photo, Aadhaar Card/Passport, Birth Certificate, 10th Passing Certificate, Highest Qualification Marksheet, Appointment Letter (current company), CTC proof (current company), last 3 months’ salary slips, relieving/experience letters from last 2 companies, PAN Card, UAN Number
❗️ Important: Ipca does not request any payment for employment and has not authorized any agency or individual to collect fees or charges for recruitment.
Interested candidates meeting the criteria are welcome to walk in directly on the date and time above.
