Regulatory Affairs Director

Job Overview Direct, oversee and manage large, complex, regulatory projects, ensuring quality deliverables on time and within budget. Responsibilities Act as a Project Manager for large and complex stand‑alone projects or programmes, involving multiple regulatory or technical deliverables, regions, and/or operations. Undertake risk analysis, management and contingency planning. Ensure that regulatory colleagues on the project have the tools and training needed to undertake the various tasks. Provide strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions to produce consistent results. Ensure compliance of regulatory processes and prepare for full Regulatory Affairs Systems Audits, and be accountable for subsequent action plans. Competently manage meetings and expectations with Regulatory Agencies and/or groups within IQVIA. Take leadership role in bid defense strategy and planning. Act as a global regulatory or technical representative in major cross‑functional global initiatives, or lead a global regulatory/technical initiative. Lead or 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. Address complex problems by drawing from best practices, deep analysis, and expertise. Qualifications Bachelor's Degree in Life Sciences or a related discipline. Minimum ten years of relevant experience, including eight years in regulatory roles. Extensive knowledge of multiple job areas, viewed as a leading expert within the field by peers. Extensive experience in regulatory and/or technical writing. Advanced negotiating and influencing skills, with ability to identify and resolve issues using a flexible, adaptable approach. Calm, assertive, and diplomatic in challenging interactions with customers. Strong software and computer skills, including Microsoft Office applications. Role model to junior colleagues, possessing a positive attitude and communication style toward customers and colleagues. Effectively communicates with all levels of the organization and remains motivated in times of change and pressure. Ability to exercise independent judgement and take calculated risks when making decisions. Applicable certifications and licenses as required by country, state, and/or other regulatory bodies. Compensation and Benefits Potential base pay range: $128,800.00 – $358,800.00 annually. Incentive plans, bonuses, and other compensation may be offered, along with a range of health and welfare benefits. Equal Opportunity Employer IQVIA is a proud equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. #J-18808-Ljbffr IQVIA LLC