Associate Director, Regulatory Affairs

Regulatory Affairs Director

Durham, United States of America | Home-based

Direct, oversee and manage large, complex, regulatory projects, ensuring quality deliverables on time and within budget.

Essential Functions

• 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

Qualifications

• 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

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.

IQVIA is proud to be an 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.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $128,800.00 - $358,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). 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.

Where You'll Work

Home-based

You'll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you'll stay connected while enjoying the autonomy and balance that comes with a fully remote role.