Senior Director, Regulatory Affairs

Job Overview
Line Management responsibilities for multiple Regulatory Affairs sites and/or region.  Responsible for the development of regulatory business, in accordance with Global Regulatory Affairs and Corporate business plans.  Participates in project-related work, as necessary.

Essential Functions
• Sr Dir, Reg Affairs

Qualifications
• Other Line Management responsibilities for multiple Regulatory Affairs sites and/or region. Responsible for the development of regulatory business, in accordance with Global Regulatory Affairs and Corporate business plans. Participates in project-related work, as necessary. Req
• High School Diploma or equivalent Master's or Bachelors Degree in Lifescience or related discipline
• Science degree preferred, i.e. biology or microbiology, or biotechnology, pharmacy.
• Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for meeting regional or global objectives.
• Strong, proven leadership skills and the ability to work effectively with senior management and delivers positive messages to staff
• Ability to make difficult judgment calls within sphere of responsibility.  Demonstrates advanced negotiating, influencing and motivating skills, with the ability to identify and resolve issues at a senior level within IQVIA and customer organization
• Act as a role model for professionalism and a respected ambassador for the Regulatory Business Unit, remaining effective in difficult, stressful and/or highly sensitive situations
• Ability to communicate effectively at all levels in the organization, consistently demonstrating confidence and authority within remit
• Sound financial awareness
• Strong software and computer skills, including MS Office applications

Using broad management discretion, direct, oversee and manage complex, regulatory project(s), ensuring quality deliverables on time and within budget. Ensure that all work is completed in accordance with SOPs, policies and practices.

Experience

Typically requires a minimum of 10 years of prior relevant experience.

Knowledge

Requires exceptional business knowledge to drive results for the organization.

Applies extensive business and industry expertise and provides organizational thought leadership.

Education

High School Diploma or equivalent

Master's or Bachelors Degree in Lifescience or related discipline preferred

Skills and Abilities

Extensive experience in regulatory and/or technical writing and/or process management

Ability to make difficult judgment calls within sphere of responsibility.  Demonstrates advanced negotiating, influencing and motivating skills, with the ability to identify and resolve issues at a senior level within IQVIA and customer organizations

Strong software and computer skills, including MS Office applications

Acts as a role model for professionalism and a respected ambassador for the Regulatory Business Unit, remaining effective in difficult, stressful and/or highly sensitive situations

Ability to accept senior management decisions and deliver positive messages to peers

Ability to communicate effectively at all levels in the organization, consistently demonstrating confidence and authority within remit

Ability to monitor the market and demonstrate knowledge of competitors and clients

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.