Regulatory Affairs Specialist

Key Responsibilities

• Support preparation, compilation, and submission of regulatory documents (INDs, amendments, annual reports, briefing packages) to FDA and/or other health authorities
• Track and maintain regulatory submission timelines and correspondence logs
• Cook up cross-functional input (clinical, CMC, nonclinical, quality) for submission-ready documents
• Maintain a watchful eye on changes in regulatory guidance and assess their impact on ongoing programs
• Support preparation for regulatory agency meetings, including briefing document development
• Maintain regulatory files and ensure inspection/audit readiness
• Aid with labeling review and other regulatory deliverables as programs progress

Qualifications

• Bachelor's degree in life sciences, regulatory affairs, or related field; RAC certification a plus
• 3+ years of regulatory affairs experience in pharma or biotech, with hands-on submission experience
• Working knowledge of FDA regulations and ICH guidelines; global submission experience a plus
• Strong writing, organizational, and project management skills
• Experience using regulatory information management (RIM) systems and eCTD publishing tools a plus
• Comfortable working independently and adapting to shifting priorities in a smaller, fast-moving organization