Associate Director, Regulatory Affairs

📋 Description

• Provide regulatory guidance to project teams and key study-level sub-teams, interpreting regulatory
• Develop and implement competitive global regulatory strategies for assigned programs and identify
• Own regulatory activities at the molecule and study levels, including clinical trial applications
• Manage regulatory submission processes, timelines, tracking tools, documentation, archives, and
• Monitor and manage regulatory agency queries and commitments, coordinating with subject matter
• Provide regular regulatory status updates, including progress against outstanding conditions

🎯 Requirements

• Bachelor’s degree in Biotechnology, Biological Sciences, or a related field required; a graduate
• At least 5 years of relevant regulatory affairs experience within the biopharmaceutical or
• Strong knowledge of U.S. FDA and international pharmaceutical regulations, guidance, drug
• Demonstrated experience working in complex, matrixed organizations and collaborating with multiple
• Proven experience interacting directly with regulatory agencies and health authorities
• Experience supporting global regulatory strategies and submissions throughout clinical development

🎁 Benefits

• Base salary range of $168,000–$198,000 USD
• Total compensation may also include bonus, stock, benefits, and other applicable variable
• Fully remote position within the United States
• Opportunity to contribute to global oncology programs addressing significant unmet medical needs
• Exposure to complex international regulatory strategies and health authority interactions
• Collaboration with multidisciplinary teams across clinical development and regulatory functions