US Regulatory Affairs Lead

Job Summary

A company is looking for a US Regulatory Lead to manage regulatory strategies for product development and lifecycle management.

Key Responsibilities

• Align local regulatory requirements with corporate standards and execute regulatory strategies
• Plan and manage local regulatory submissions, ensuring compliance with corporate and local requirements
• Act as the point of contact with regulatory agencies and provide guidance on local regulatory compliance

Required Qualifications

• Doctorate degree, or Master's degree with 2 years of related experience, or Bachelor's degree with 4 years of related experience, or Associate's degree with 8 years of related experience, or High school diploma/GED with 10 years of related experience
• Knowledge of regulatory principles and in-depth regulatory experience in applicable countries
• Understanding of country legislation and regulations related to medicinal products
• Experience with policies, procedures, and standard operating procedures (SOPs)
• Familiarity with drug development processes and regulatory challenges in the relevant country(ies)