We’re seeking an Executive Vice President of Regulatory Affairs for the Pharmaceutical/Biotech Industry. Ideal candidates will have both domestic and international regulatory experience.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
? Routinely represents company to high level external stakeholders, including the board of directors, donors, government officials and various stakeholders
? May be required to function in an acting capacity when the CEO and/or CFO are traveling or otherwise not available
? Identify, evaluate, and develop strategic collaborations with industry, academic, and government institutions
? Provide visible leadership for the company within the relevant regulatory communities, both locally and world-wide
? Provide information to the CEO, Donors, and Board of Directors as required
? Give technical presentations at seminars, conferences, meetings as requested
? Participate in business development activities as regulatory and quality spokesperson
? Provide guidance to research programs conducted by the company and its partners to achieve successful regulatory submissions.
? Cultivate positive professional relationships with global regulatory authorities in obtaining their opinions and guidance, interpreting their requirements, making submissions and subsequent interactions
? Directly manage regulatory submissions, coordinating the efforts of all supporting staff
? Plan, recruit, hire and manage performance of internal staff
? Plan and execute annual budgets for Regulatory Affairs
? Contract for and manage external resources as required
? Ph.D. or M.D. in a relevant field
? 15+ year’s experience with increasing responsibility
? Experience in the HIV field
? Regulatory experience with foreign agencies and INDs
? A strong record of performance in regulatory submissions and approvals, including direct interaction with FDA in developing acceptable research plans and successfully responding to agency issues.
Knowledge, Skills, and Abilities
? Excellent interpersonal, presentation, and communication skills, with the ability to represent the company to outside constituencies
? Effective leadership and management skills
? Culturally sensitive, diplomatic and politically savvy to interact with a wide variety of constituents globally
? Proven leadership and organizational skills in staff development and project management
? Well-developed research and analytical skills. Must think strategically yet oversee tactical implementations
? Must be able to coach a diverse group of employees, identify critical milestones, and hold teams and individuals accountable for strategic objectives
? A positive, determined attitude and the creativity and resourcefulness to navigate around obstacles and achieve favorable regulatory conclusions.
? Excellent verbal and communication skills
? Adherence to the highest professional and ethical standards