• The Director, Regulatory Affairs provides Regulatory support to the development team to ensure that the development plan provides for the highest Regulatory probability of success. Serves as Regulatory representative/expert in cross-functional development teams and may support business development assessments of external opportunities, providing advanced regulatory solutions and guidance to cross-functional teams.
• The individual plans, prepares, and reviews submissions to regulatory agencies including FDA, EMA, and other global health authorities to support the conduct of clinical trials and approval of marketing applications. The role will assist in development of submission plans and timelines and serves as a primary point of contact with Regulatory Agencies and leads communication/meeting strategy development and execution.
• The individual will eventually develop and mentor Regulatory personnel and future Regulatory leaders, manage Regulatory budget, and partner with Quality to assist in management of external inspections/assessments of facilities.
• A minimum of a B.A./B.S. within a technical related discipline is required. M.S., M.E., Ph.D. or M.D. is a plus.
• At least 8 years of relevant / regulated industry experience is required.
• Knowledge of drug development process and regulatory guidelines
• Demonstrated, hands-on experience leading, managing and preparing regulatory submissions.
• Demonstrated track record of successful regulatory approvals and strategies in major business regions.
• Prior regulatory agency liaison experience with a major regulatory agency.
• CMC Regulatory experience is a plus.
• Compliance, auditing experience is a plus.
• Ability to lead cross-company and cross-franchise teams to meet common business objectives.
• Ability to manage and resolve complex domestic and international regulatory issues.
• Ability to utilize regulatory experience to create and execute worldwide vision and strategies.
• Ability to apply superior technical writing skills to job duties and tasks.
• Ability to effectively communicate using both oral and written communication skills.
• Ability to prioritize and handle multiple projects simultaneously.
• Ability to apply high level of ethics.