Regulatory Affairs Consultant

Job Summary

A company is looking for a Regulatory Affairs Consultant III.

Key Responsibilities

• Provide strategic and operational Regulatory CMC expertise and support in cross-functional teams
• Prepare and deliver CMC Regulatory operational plans and submissions to Health Authorities
• Manage routine and non-routine Health Authority interactions and monitor changes in the Regulatory CMC environment

Required Qualifications

• 3-5 years of relevant experience in the pharmaceutical industry or regulatory authority CMC review capacity
• Experience in authoring CMC submission documents for development and/or marketed products
• Knowledge of GMP requirements and standard systems
• Proven ability to lead cross-functional teams within a matrix organizational structure
• Experience in direct communication and negotiation with regulatory agencies on CMC matters