Regulatory Affairs Director

Job Overview

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

About the role

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
Ensures 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
Acts as global regulatory or technical representative in major cross-functional global initiatives and/or may lead a global regulatory/technical initiative
Leads/chairs a session on Regulatory Affairs or related topics at a conference; delivers effective presentations to a broad audience
Responsible for making major improvements to processes and systems across functions or large departments

Qualifications

• Bachelor's Degree in Lifescience or related discipline
• 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

Skills

Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

Benefits

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.

Pay

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).

Schedule

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.