Regulatory Affairs Senior Manager

Job Summary

To support the development of innovative treatments, the full-time remote Regulatory Affairs Senior Manager will manage US regulatory strategies, execute regulatory plans, and ensure compliance for products in the obesity and metabolic disease therapeutic area.

Key responsibilities

• Execute the US regulatory plan to obtain and maintain Clinical Trial Authorizations and Marketing Application approvals
• Develop US regulatory strategies and provide content for regulatory documents and meetings in alignment with GRT strategy
• Maintain awareness of new legislation and provide regulatory guidance to optimize product development

Required qualifications

• Doctorate degree with 2 years of experience, or a Master's degree with 4 years, or a Bachelor's degree with 6 years, or an Associate's degree with 10 years, or a high school diploma/GED with 12 years of experience in regulatory or pharmaceutical drug development
• Experience in the cardiometabolic therapeutic area is highly preferred
• Regulatory submissions experience (e.g., INDs or CTAs)
• Knowledge of regulatory principles and national legislation relating to medicinal products
• Experience interacting with regulatory agencies