Principal Specialist, Regulatory Affairs

A growing biotechnology company is seeking a Principal Specialist, Regulatory Affairs (Health Authorities) to support global regulatory strategy and health authority submissions for investigational and marketed products. This role will partner closely with Clinical, Regulatory, and cross-functional teams to advance development programs and support critical regulatory filings.

Key Responsibilities

• Support global regulatory strategy and health authority interactions.
• Prepare and review INDs, CTAs, NDAs, BLAs, MAAs, and briefing documents.
• Draft responses to health authority questions and information requests.
• Review clinical data, reports, and submission content for accuracy and compliance.
• Support eCTD submissions and document management activities.
• Provide regulatory guidance to cross-functional teams.
• Monitor evolving global regulatory requirements and guidance.
• Support process improvements and special regulatory projects.

Qualifications

• Bachelor's degree with 10+ years or Master's degree with 8+ years of regulatory affairs experience.
• Experience supporting clinical regulatory submissions in eCTD format.
• Familiarity with health authority interactions and information request responses.
• Knowledge of global regulatory requirements and clinical development.
• Strong understanding of GCP and clinical documentation.
• Excellent organizational, communication, and project management skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Global submission experience is a plus.