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Executive Vice President, Regu...

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Job Summary

Silver Spring, MD
Job Type
Full Time
Years of Experience
More than 15 Years
Education Level
Career Level
Executive (SVP, VP, Department Head, etc)

Job Reference Code

Executive Vice President, Regulatory Affairs

About the Job

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.


Job Responsibilities

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


Job Specifications/Qualifications

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



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