Job Description

Principal Scientist role leading global regulatory strategy for oncology products at a major pharmaceutical company. Serves as primary regulatory contact for assigned projects, managing interactions with health authorities and coordinating cross-functional teams to optimize product labels and accelerate time to approval.

Responsibilities

• Develop and implement worldwide regulatory strategy for oncology products across multiple indications to optimize labeling and approval timelines
• Serve as global point of contact for assigned programs, independently managing projects and interactions with regulatory agencies
• Lead global regulatory teams providing cross-functional support for development and marketed products throughout drug lifecycle
• Prepare and coordinate submissions to regulatory agencies; review and approve all associated documentation before external release
• Represent company in FDA meetings, advisory committees, and interactions with foreign regulatory bodies across multiple regions

Requirements

• Bachelor's degree in biological science, chemistry, or related field with 10+ years drug development, clinical, or regulatory experience
• Master's degree with 10+ years relevant experience, or PhD with 7+ years, or MD with 5+ years
• Led or directly supported FDA, EMA, or other health authority meetings
• Led or directly supported regulatory filings and submissions
• Strong strategic thinking and ability to work independently with minimal oversight
• Excellent verbal and written communication skills

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