Regulatory Affairs Manager

Job Overview

• Effectively collaborates with operational colleagues to manage project- and team-related challenges.
• Contributes to discussions on implementation of business strategy on a regional basis and will implement regional and global specific objectives, as appropriate; Undertakes risk analysis and manages the outcome as appropriate.
• May provide strategic regulatory and/or technical consultancy on a variety of projects.
• Competently manages meetings/expectations with Clients and/or groups within IQVIA.
• Actively participates in project scoping calls and proposal development
• Prioritizes own work load and the work load of the project team in order to achieve the project scope and objectives.
• May act as a trusted advisor to clients, often on issues that lack precedence or are not yet clearly defined.
• 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;
• Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with DDRS management and account management.
• Continually looks for process improvements.
• Routinely takes a proactive role in developing long standing relationships with preferred IQVIA customers and routinely takes a leadership role in bid defence strategy and planning, as appropriate.
• Defines self-development activities in order to keep current within the industry (e.g. maintain membership in a relevant industry and/or scientific/technical association).
• May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience.

Requirements:

• Minimum 5 years’ experience in RA, including 1–2 years in international RA
• Preferred majors: medical, pharmacy, or other life sciences
• Familiarity with international RA (primarily USA and Europe)
• Proficient in English
• Strong communication skills and sense of responsibility

Preferred Skills / Experience

• Demonstrated ability to influence cross-functional teams and build long-term client relationships
• Experience acting as a Project Manager for regulatory projects
• Experience participating in proposal development, bid defense activities, or other client-facing business initiatives
• Understanding of CRO, consulting, or drug development service environments
• ASAP

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 https://jobs.iqvia.com

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. We appreciate your honesty and professionalism.