Dir, Reg Affairs

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

Job summary

Regulatory Toolkit is seeking a seasoned Regulatory Affairs leader to manage a site or multiple locations in the U.S. You will oversee staff performance, strategic planning, and regulatory compliance across regions, influencing global objectives and delivering results.

You will lead a team with full financial accountability for the sites, drive risk management, and collaborate with senior stakeholders to implement regulatory programs and ensure timely project delivery in a dynamic environment.

Qualifications

• Bachelor's Degree in Lifescience or related discipline.
• Master's Degree in Lifescience or related discipline.
• 8+ years regulatory experience including 6+ years in management.
• Line management experience with success in development, engagement and performance of senior staff.
• Advanced negotiating and influencing skills and the ability to identify and resolve issues.
• Acute awareness of issues outwith the business function and ability to lead by example.
• Ability to work with senior management and drive regulatory strategy and change.

Responsibilities

• Lead staff in accordance with policies and regulations, including salary administration.
• Manage resources, delegate tasks, and monitor workload, quality, and metrics.
• Collaborate with operations to manage project- and team-related challenges.
• Implement regional and global objectives and strategic plans.
• Maintain financial accountability for one or more Regulatory Affairs sites.
• Conduct risk analyses and manage outcomes.
• Serve as Project Manager for large, complex projects or programs.
• Provide strategic regulatory/technical consultancy on projects.
• Lead meetings with Regulatory Agencies and bid defense strategy.

Skills

Line management

Regulatory experience

Negotiation

Communication

Financial awareness

Stakeholder management

Problem solving

MS Office

Education

Bachelor's Degree Lifescience

Master's Degree Lifescience

Tools

MS Office

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.