Dir, Reg Affairs

IQVIA; Durham (NC); On-site; USD 129,000 - 359,000; Full time

Job summary

IQVIA in Durham, NC is seeking an experienced Line Manager for Regulatory Affairs to lead a site or several sites, overseeing staff, budgeting, and compliance with regulatory standards.

The role requires strong leadership, regulatory expertise, and the ability to align regional and global objectives with site operations. You will mentor staff, drive performance, and manage complex regulatory projects as needed.

Qualifications

• Bachelor's degree in Life science or related discipline.
• Master's degree in Life science or related discipline.
• 8+ years regulatory experience including 6 years management.
• Line management experience with development and performance of senior staff.
• Advanced negotiating and influencing skills; calm under pressure.
• Ability to lead and communicate regulatory strategic plans to senior management.
• Strong MS Office skills.
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.

Responsibilities

• Lead staff in accordance with policies and regulations; plan, assign, direct, appraise performance, and manage HR actions.
• Monitor workload, quality, and metrics; review and report findings.
• Collaborate with operations to address project and team challenges.
• Implement regional/global objectives and strategic plans; manage regional/regulatory initiatives.
• Ensure understanding of strategy and lead implementation efforts.
• Take financial responsibility for one or more sites; monitor growth and performance.
• Conduct risk analysis and manage outcomes.
• Act as Project Manager for large/complex regulatory projects or programs.
• Provide strategic regulatory/technical consultancy as needed.
• Lead/participate in meetings with regulatory agencies and IQVIA groups.

Skills

Line management

Budgeting / financial accountability

Regulatory affairs knowledge

Staff development

Negotiation skills

MS Office

Education

Bachelor's Degree in Life sciences

Master's Degree in Life sciences

Job description

Job Overview

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

Essential Functions

• 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 Degree in Lifescience or related discipline Req Or
• Master's Degree 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

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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

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.

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). 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.