Regulatory Affairs Director

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
Bachelors 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. Learn more at

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. 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.