Director of Regulatory Affairs

Tasks

• Develop and implement regulatory strategy
• Prepare regulatory submissions of regulatory applications, such as, INDS, NDAs, MAAs, related supplements, responses to questions from government authorities regarding regulatory submissions, and annual reports
• Interact directly with health authorities, including FDA, to facilitate assessment of IND and NDA applications
• Organize and manage meetings with Health Authority personnel to obtain commitments and agreements enabling rapid and compliant development of new drug programs
• Partner with program team and cross-functional colleagues to coordinate regulatory submissions in support of ongoing and future global clinical studies
• Review and submit final clinical and nonclinical study reports, and other development-related documents
• Write regulatory documents to support regulatory submissions
• Provide regulatory oversight and guidance to project teams on compliance matters, FDA and other competent authority requirements, clinical study design issues and on timing, logistics and operational
• Prepare risk assessment profiles for regulated aspects of new drug development and communicate risk assessment to senior management
• Ensure compliance with laws and regulations governing clinical trial disclosure
• Establish relevant processes and procedures to support the Regulatory Affairs functional activities
• Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements

Requirements

• Bachelor's degree in life sciences required; advanced degree preferred
• 10+ years pharmaceutical industry regulatory experience
• Experience in multi-national development, registration and marketing requirements
• Familiarity with CTD formats
• Strong leadership abilities and excellent communication/interpersonal skills; must exhibit ability to influence decision-making and effect implementation of regulatory strategies and considerations in alignment with organizational goals
• Demonstrated strategic development capabilities related to new drug development and commercial support activities
• Knowledge of FDA and international requirements for sections of IND, NDA and international filings as well as clinical trial disclosure requirements
• Experience in effective communication with FDA and other regulatory agencies
• Excellent written and oral communication skills
• Excellent interpersonal skills
• Strong project management skills and drive for excellence