IQVIA · 19 hours ago
Associate Director, Regulatory Affairs
Washington, DC
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$108K/yr - $300K/yr
8+ years expIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. They are seeking an Associate Director of Regulatory Affairs to manage complex regulatory projects, ensuring quality deliverables on time and within budget while providing strategic regulatory consultancy and mentorship to junior colleagues.
AnalyticsHealth CareLife Science
Responsibilities
May act as a Project Manager for a large stand-alone programme, involving several regulatory or technical deliverables and/or region, and/or operation; Undertakes risk analysis, management and contingency plans, as appropriate
Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate
May manage meetings with Regulatory Agencies
May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients
Provides mentorship to junior colleagues and advise others on many regulatory document types
May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications
May be assigned as Reviewer and/or Approver for Regulatory standard operating procedures or cross-functional standard operating procedures owned by other operations
May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative
Performs other tasks or assignments, as delegated by Regulatory management
Qualification
Required
Bachelor's Degree Degree in Lifescience or related discipline Req Or
Master's Degree Degree in Lifescience or related discipline
At least 8 years relevant experience including 6 years regulatory experience or combination of education, training and experience
Extensive experience in regulatory and/or technical writing
Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
Strong software and computer skills, including MS Office applications
Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues. Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations
Ability to exercise independent judgement taking calculated risks when making decisions
Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
Benefits
Incentive plans
Bonuses
Health and welfare and/or other benefits
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$3.5B2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Jonathan Morris
VP & GM US Healthcare
Recent News
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