Dir, Reg Affairs

About the role

Line Management responsibilities for a Regulatory Affairs site or combination of sites.

Responsibilities

• Manage staff in accordance with organization’s policies and applicable regulations; responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; approve actions on human resources matters, including salary administration;
• Effectively manages the team's resources and delegates tasks commensurate with skill level; evaluates workload, quality and metrics through regular review and reporting of findings;
• Effectively collaborate 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;
• Ensures staff have a consistent understanding and positive impression of strategy for regional and global objectives; leads strategic initiatives and develops implementation plans;
• Will have full financial responsibility and accountability for one or more Regulatory Affairs sites; monitors growth and performance of the sites;
• Undertakes risk analysis and manages the outcome as appropriate;
• 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;
• May provide strategic regulatory and/or technical consultancy on a variety of projects;
• Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA;
• May take leadership role in bid defense strategy and planning;
• May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience;

Qualifications

• Bachelor's Degree in Lifescience or related discipline (Req) OR Master's Degree in Lifescience or related discipline
• At least 8 years regulatory experience including 6 years management experience
• Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff
• Line management experience required, with demonstrated success in development, engagement and performance of senior staff
• 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 and staff
• Possesses an acute awareness of issues outwith the business function. Exudes confidence and authority within remit, and delivers a positive example to teams
• Communicates an inspiring vision of the Regulatory Strategic Plan and helps others understand and value their role in it.
• Ability to work effectively with senior management, remaining motivated and enthusiastic in times of change and other pressure situations
• Sound financial awareness
• Strong software and computer skills, including MS Office applications
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

Pay

The potential base pay range for this role, when annualized, is $128