Regulatory Affairs Director

IQVIA

Regulatory Affairs Director managing complex regulatory projects and ensuring quality deliverables on time at IQVIA. Leading cross-functional initiatives in regulatory compliance and consultancy.

Posted 7/2/2026full-timeDurham • Arizona, Illinois, New Jersey, North Carolina • 🇺🇸 United StatesLead💰 $128,800 - $358,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive regulatory expertise and project management capabilities, ensuring compliance and quality deliverables while effectively leading cross-functional initiatives. Possesses strong negotiation, communication, and problem-solving skills to navigate complex regulatory environments.

Highest-signal resume keywords

Regulatory Project ManagementRegulatory WritingRisk Analysis and ManagementStrategic Regulatory ConsultancyLeadership in Regulatory Affairs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Project ManagementRegulatory WritingRisk AnalysisContingency PlanningRegulatory ComplianceProcess ImprovementTechnical ConsultancyNegotiation SkillsProblem SolvingIndependent Judgement

Soft Skills

Effective CommunicationLeadershipAdaptabilityDiplomacyPositive Attitude

Tools & Technologies

Microsoft Office Applications

Industry Keywords

Regulatory AffairsLifescienceRegulatory Systems AuditsCross-Functional InitiativesBid Defense Strategy

About the role

Key responsibilities & impact

Direct, oversee and manage large, complex, regulatory projects, ensuring quality deliverables on time and within budget.
May act as a Project Manager for a large and complex stand-alone project or programme, involving several regulatory or technical deliverables and/or region, and/or operations
Undertakes risk analysis, management and contingency plans
Must ensure that regulatory colleagues on the project have the tools and training needed to undertake the various tasks
Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results
Ensures compliance of regulatory processes and prepares for full Regulatory Affairs Systems Audits, accountable for any subsequent action plans
Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA
May take leadership role in bid defense strategy and planning
May act as global regulatory or technical representative in major cross-functional global initiatives and/or may lead a global regulatory/technical initiative
May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience
Responsible for making major improvements to processes and systems across functions or large departments
Problems faced are highly complex and require solutions drawn from best practices and expertise, as well as from extensive analysis into the root cause.

Requirements

What you’ll need

Bachelor's Degree Lifescience or related discipline Required
At least 10 years relevant experience including 8 years regulatory experience
Requires extensive knowledge of multiple job areas obtained through advanced education and experience; Viewed as a leading expert within the field by peers
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 Microsoft 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

Comp & perks

Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.