Regulatory Affairs Site Manager

We are seeking a Regulatory Affairs Site Manager to oversee Regulatory Affairs sites or a combination of sites. As a key member of our team, you will have Line Management responsibilities, managing staff, and ensuring compliance with organisational policies and regulations.

Key Responsibilities:

• Manage staff in accordance with organisational policies and applicable regulations
• Plan, assign, and direct work, appraise performance, and guide professional development
• Evaluate workload, quality, and metrics through regular review and reporting of findings
• Collaborate with operational colleagues to manage project- and team-related challenges
• Contribute to discussions on implementation of business strategy on a regional basis and implement regional and global specific objectives
• Ensure staff have a consistent understanding and positive impression of strategy for regional and global objectives
• Lead strategic initiatives and develop implementation plans
• Have full financial responsibility and accountability for one or more Regulatory Affairs sites
• Monitor growth and performance of the sites
• Undertake risk analysis and manage the outcome as appropriate
• Act as a Project Manager for large and complex stand-alone projects or programmes
• Provide strategic regulatory and/or technical consultancy on various projects
• Competently manage meetings/expectations with Regulatory Agencies and/or groups within IQVIA
• Take leadership role in bid defence strategy and planning
• Lead/chair sessions on Regulatory Affairs or related topics at conferences and deliver effective presentations

Requirements:

• Bachelor's or Master's Degree in Life Science or related discipline
• At least 8 years regulatory experience, including 6 years management experience
• Demonstrated working knowledge of corresponding professional grade level responsibilities, skills, and abilities
• Line management experience with demonstrated success in development, engagement, and performance of senior staff
• Advanced negotiating and influencing skills
• Ability to work effectively with senior management and remain motivated and enthusiastic in times of change and pressure
• Sound financial awareness and strong software and computer skills, including MS Office applications
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

What We Offer:

• Competitive salary: $128,800.00 - $358,800.00 per year
• A range of health and welfare and/or other benefits