Director of Regulatory Affairs

Position Summary

The Director of Regulatory Affairs provides strategic and operational leadership to the development and commercialization of products for one or more of the Company’s clinical programs. Reporting to the SVP, Regulatory Affairs, the right experienced candidate will be a collaborative leader to work across the organization in this senior regulatory role to help us build the required capabilities to bring our products to patients.

Responsibilities

• Develop and implement regulatory strategy and 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.

Qualifications

• 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