Job Overview

Supervises support level employees and sets day-to-day operational objectives for team.

Essential Functions

• Responsible for performance (quality, profitability, utilisation) of direct reports, ensuring consistent regulatory support, in accordance with Global Regulatory Affairs business plans. Ensures objectives of individual staff and teams are in line with overall Regulatory Affairs objectives by facilitating regular communications;
• Participate in the selection and on-boarding process for new Regulatory staff by conducting candidate review and participating in the interview process. Ensure staff have the appropriate materials, systems access and training to complete job responsibilities;
• May act as a Lead Regulatory Professional or Project Manager on any type of writing or technical project and may provide strategic regulatory or technical consultancy;
• May prepare a single service regulatory or technical proposal for senior review and/or propose budgets for less routine projects, out of scope activities and potential budget efficiencies. Deliver business development presentations to customers with confidence and detailed knowledge, as directed;
• Independently meet with customers face to face to discuss project status. Identifies creative solutions to challenges that are acceptable to Quintiles and customers, thereby consistently receiving positive customer feedback;
• Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate;
• May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff;
• May write new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
• Builds strong relationships with managers of other operations and acts as a positive ambassador for Regulatory Affairs;
• Responsible for leading moderate to significant improvements of processes, systems or products to enhance performance of job area;
• Ensures compliance with regulatory processes, ensuring readiness for internal or external project audits.
• May design training materials and deliver training externally and internally;

Qualifications

• Other Bachelors or Master's Degree in Pharmacy
Req Or
• At least 8 years relevant experience
Req
• Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff
• Demonstrate success in leading teams or previous experience in a supervisory capacity.
• 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
• Sets a positive example to staff, relating to professionalism, attitude and interaction with colleagues and customers
• Understands and promotes Corporate and Global Regulatory Affairs Business Unit strategies, communicating this in a positive manner to staff
• Ability to provide fair, timely, appropriate and constructive feedback and guidance to staff
• Ability to earn trust of staff, acting in confidence and with sensitivity when dealing with personnel issues, staff expectations and conflict management
• Demonstrates confidence and appropriate communication style in representing staff issues or concerns to senior management
• Strong software and computer skills, including MS Office applications

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com