Walk-in || Assistant Manager - Regulatory Affairs

Location:
Mumbai (Maharashtra) or Pithampur (Madhya Pradesh) | Employment Type: Full-time

About the role:

Ipca Laboratories is hiring experienced Biosimilar Regulatory Affairs professionals to join our team as Senior Regulatory Executive (SRE) or Assistant Manager. You will lead preparation and submission of biosimilar regulatory dossiers for developed and Semi-regulated markets as well as domestic submissions (CDSCO), drive CMC documentation, and coordinate cross-functional regulatory strategies for global and domestic filings.

What were looking for?

• 6-10 years 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
  

Why Ipca?

• Established pharmaceutical company with active biosimilar programs
• Collaborative cross-functional environment and opportunities for professional growth
  
  

Only candidates with 610 years of biosimilar regulatory submission experience will be considered.