Elanco Innovation and Alliance Centre is hiring an Associate – R&D (Regulatory Affairs CMC) in Bengaluru (Hybrid). This is a high-value opportunity for professionals with 2–4 years of experience in Global Regulatory Affairs specializing in CMC (Chemistry, Manufacturing & Controls) for biotechnology and large molecule products.

If you have hands-on exposure to regulatory submissions, lifecycle management (LCM), and global compliance (FDA, EMA, VICH), this role offers strong career growth in veterinary biotech regulatory strategy.

Key Responsibilities

• Develop and execute global regulatory strategies for veterinary biotechnology products
• Manage end-to-end lifecycle management (LCM) for large molecules (mAbs, vaccines, peptides)
• Prepare and author high-quality CMC regulatory submissions
• Support global submissions, renewals, and annual reporting requirements
• Collaborate cross-functionally with R&D, Quality, Manufacturing, and Regulatory teams
• Ensure compliance with FDA (CVM), USDA (CVB), EMA, and ICH/VICH guidelines
• Drive geo-expansion strategies for marketed biotech products
• Track submission timelines and ensure documentation quality and completeness
• Stay updated with global regulatory trends and evolving guidelines

Required Qualifications

• Education: MSc / B.Pharm / M.Pharm / Veterinary Sciences or related life science degree
• Experience: Minimum 2+ years in Global Regulatory Affairs (CMC)
• Strong knowledge of:
  • CMC regulatory strategy
  • Biotechnology products / large molecules
  • Global regulatory frameworks (FDA, EMA, VICH, ICH)
• Experience in:
  • Regulatory submissions & documentation
  • Regulatory Information Management Systems (RIMS)
  • cGMP compliance requirements

Preferred Skills

• Experience with sterile injectables / fermentation-based products
• Strong analytical and decision-making skills
• Excellent written and verbal communication
• Ability to work in cross-functional global teams
• Detail-oriented with a quality-driven mindset

Benefits of This Role

• Work with a global leader in animal health (Elanco)
• Exposure to international regulatory agencies (FDA, EMA, USDA)
• Opportunity to work on cutting-edge biotechnology products
• Hybrid work model offering flexibility
• Strong career progression in Regulatory Affairs & CMC strategy

Application Process

Application Link