✨ Job Opportunity at Aculife Healthcare Pvt. Ltd (Nirma Group) – Regulatory Affairs | Ahmedabad

 Aculife Healthcare Pvt. Ltd, part of the well-known Nirma Group, is hiring for the Regulatory Affairs (RA) team at its Head Office in Ahmedabad.

This role is ideal for candidates with experience in LATAM (Brazil, Mexico) submissions and exposure to EU submission systems.

📍 Job Location

Ahmedabad, Gujarat (Corporate Office)

📝 Key Job Responsibilities

• Compile & review registration dossiers as per country-specific regulatory guidelines.

• Work with LATAM regulatory filings (Brazil, Mexico) and EU submission platforms.

• Review key technical documentation, including:

  

  • DMF

  • Product Development Report

  • BMR / BPR

  • Analytical Method Validation Report

  • Specification (STP)

  • Stability Study Report

  • BE Study Report

  • Prepare & compile deficiency responses for new product submissions and backlog dossiers.

  • Review and submit post-approval variations per updated guidelines.

  • Communicate with international regulatory teams/agents/distributors for timely filings.

  • Review artworks for existing and newly-launched products.

  • Maintain regulatory databases and central document records.

    👤 Preferred Candidate Profile

    Requirement	Details
    Experience	6 months to 2 years in Core International Regulatory Affairs
    Technical Knowledge	Strong understanding of regulatory submissions & documentation
    Interpersonal Skills	Good communication & coordination abilities
    Market Exposure	LATAM required; EU preferred

    
    

    
    

📧 How to Apply

If your experience matches the above expectations, please share your resume at:

👉 Email: satabdeerath@aculife.co.in