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Executive Vice President, Regulatory Affairs

Lab Support, A Division Of On Assignment

Silver Spring, MD, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Areas of Expertise Desired:

Job Description

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


?   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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