Regulatory Affairs Director

IQVIA • Durham, IL

1d

About The Position

Direct, oversee and manage large, complex, regulatory projects, ensuring quality deliverables on time and within budget. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Requirements

• 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

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director