Senior Regulatory Affairs Consultant

About the role

Regulatory Affairs Consulting team at Parexel focuses on guiding global CMC Biologics submissions and lifecycle management. The Senior Regulatory Affairs Consultant leads preparation and delivery of marketing authorization applications across US, EU, Japan, Canada, Switzerland and Australia, mentors junior staff, and ensures compliance with ICH regulations. Bengaluru, Remote, work-from-home arrangement with occasional virtual collaboration, relocation assistance available.

What you’ll do

• Prepare and author regulatory submissions for biologics
• Review marketing authorization applications and variations
• Guide and mentor team members on technical aspects
• Coordinate with global and regional stakeholders
• Ensure compliance with regulatory frameworks

What you’ll bring

• 10-14 years regulatory affairs experience
• Experience with CMC Biologics (vaccines, proteins, mAbs)
• Knowledge of US, EU, Japan, Canada, Switzerland, Australia regulations
• Bachelor’s degree in scientific/technical field; advanced degree preferred
• Strong communication and collaboration skills
• Team lead/mentor experience

Skills