Regulatory Affairs Director

IQVIA · Durham, NC · 1 wk ago

RemoteRemoteLegal$129k–$359k/yrFull-time

Job Overview

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 in 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

About the Role

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).

Benefits

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.

Schedule

Home-based

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.