Associate Director, Global Regulatory Affairs

The Associate Director, Global Regulatory Affairs, is responsible for the development and implementation of regulatory strategies for specific early-stage drug development programs, while serving as the regulatory lead on the respective program teams. The Associate Director will also be the regulatory contact with relevant regulatory authorities, as appropriate. The key to success will include working across cross‑functional teams, collaborating with stakeholders, project leaders, and project team members, and driving the execution of integrated development plans for drug candidates.

• Prepare and support submission to successful filing and approval for clinical trial submissions
• Develop various briefing packages and regulatory applications (e.g. orphan, expedited review pathways, etc.) to the FDA and other global health authorities, as applicable
• Develop response and submission strategies to regulatory information requests in close collaboration with cross‑functional team members
• Partner with project team leaders and functional leaders to define project strategy, develop and maintain integrated project plans, and manage diverse teams across multiple sites to meet project timelines/goals
• Continuously adapt project strategy based on internal and external information
• Identify and assess regulatory risks for assigned projects or programs
• Serve a Health Authorities contact for the assigned projects and contribute to Health Authority meetings
• Foster effective, proactive and open communication within and across project teams, build mutual respect and trust among team members to achieve transparency and clarity of program goals, progress and issues
• Contribute to development and improvement in processes, procedures, and tools related to regulatory affairs practices

• Master's in life sciences required, advanced degree (Pharm
  
  D, MD, PhD) preferred
• 7‑10+ years of relevant progressional experience, with 5+ years of regulatory affairs experience in immunology, oncology or rare diseases
• Previous track record of success working with multidisciplinary drug development teams and managing international development projects
• Demonstrate strong organizational skills, including the ability to prioritize topics and workload
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel (e.g., clinical, scientific, QA and CMC staff)
• Experience in interfacing with relevant regulatory authorities
• Experience and knowledge in the preparation of regulatory documents, including interpretation of regulations, guidelines, policy statements, etc.