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Executive Vice President, Regu...
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
Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities:
§ 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