Senior Manager, Regulatory Affairs

Job Summary

A company is looking for a Senior Manager, Regulatory Affairs.

Key Responsibilities

• Act as the Regional Regulatory Lead (RRL) for assigned projects in various regions
• Develop regional regulatory strategies in collaboration with the Global Regulatory Lead (GRL)
• Manage the preparation and submission of complex regulatory submissions in compliance with regional requirements

Required Qualifications, Training, and Education

• BA/BS in a scientific discipline required; MS/PharmD preferred
• Experience in core regulatory environments and leading complex regulatory submissions
• In-depth knowledge of regulatory landscape and ICH guidelines
• Experience with direct interactions with health authorities such as FDA and EMA
• Ability to work independently with minimal supervision