RA Consultant

About This Role

This role will develop and execute global regulatory strategies for clinical development programs, focusing on virology assets for a cutting-edge biotech client. This position is a contract-to-hire opportunity, ideal for a hands-on regulatory professional.

Responsibilities

• Develop and implement global regulatory strategies aligned with clinical development plans
• Lead the preparation, review, and submission of regulatory filings, including IND/CTA amendments and briefing packages
• Act as the primary regulatory contact for health authority interactions and meetings
• Provide regulatory guidance to cross-functional teams, including Clinical, CMC, Nonclinical, and Quality teams
• Monitor regulatory intelligence and assess its impact on development programs
• Support regulatory aspects of clinical trial execution and lifecycle management
• Manage external vendors and consultants as needed
• Ensure compliance with applicable global regulations and guidelines

Requirements

• Advanced degree in life sciences or a related field
• Experience in Regulatory Affairs within biotech or pharmaceutical industries
• Proven expertise in clinical-stage regulatory submissions
• Strong knowledge of FDA and EMA regulatory frameworks
• Ability to work independently while effectively collaborating across teams
• Excellent written and verbal communication skills

Qualifications

• Advanced degree in life sciences or a related field (PhD, PharmD, MD preferred; MS with strong experience considered)