Senior Regulatory Affairs Manager - Oncology - Remote

Overview

The Senior Regulatory Affairs Manager - Oncology will provide direct regulatory support for Oncology IVD/CDx products in all stages of the product lifecycle, leading regulatory strategies and submissions primarily for the US market.

In Short

• Lead regulatory support for Oncology IVD/CDx products.
• Manage FDA submissions including pre-market and post-market regulatory submissions.
• Represent regulatory affairs in cross-functional project teams.
• Review project and submission documentation.
• Support regulatory compliance throughout the product lifecycle.
• Facilitate product approvals through effective communication with regulatory agencies.
• Manage regulatory workflow and project deliverables.
• Coordinate responses to regulatory agency requests.
• Provide strategic advice based on regulatory expertise.
• Maintain a cooperative working environment.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• 7+ years of regulatory affairs experience in IVD, or 5+ years with an advanced degree.
• Proven success in leading FDA regulatory submissions.
• Strong knowledge of IVD/CDx development processes.
• Excellent analytical and communication skills.
• Highly organized with the ability to manage multiple priorities.
• Self-motivated and capable of working independently.
• Hands-on, proactive, and solutions-oriented.
• Proficient with Microsoft Office and project management tools.
• Experience with AI tools is a plus.

Benefits

• Flexible hybrid work model.
• Competitive salary range.
• Comprehensive benefits package.
• Opportunity to work in a leading precision oncology company.
• Collaborative and innovative work environment.