Associate Director, Regulatory Affairs

IQVIA • Durham, NC

1d • $103,600 - $288,600

About The Position

The Associate Director, Regulatory Affairs provides line management for a team of Regulatory staff or may oversee the performance of one or more Regulatory Affairs sites. The role develops regulatory business in accordance with Global Regulatory Affairs business plans and participates in project-related work as needed. It may include site-level financial accountability, business development, project management, regulatory and technical consultancy, engagement with Regulatory Agencies, and client-facing proposal work.

The position manages staff and personnel matters, coordinates projects and resources, supports the implementation of regional and site-specific objectives, and builds relationships across operations. It leads moderate to significant improvements to processes, systems, or products and may support global or regional regulatory initiatives. The role also may review or approve regulatory and cross-functional standard operating procedures, deliver workshops or presentations, and perform other duties as business needs require.

Requirements

• Bachelor's degree in Life Science or a related discipline, or a master's degree in Life Science or a related discipline.
• At least 6 years of regulatory experience, including 3 years of management experience, or an equivalent combination of education, training, and experience.
• Specific regulatory or technical expertise.
• Line management experience, with demonstrated success in staff development, engagement, and performance.
• Demonstrated success leading teams or previous supervisory experience.
• Good interpersonal, oral and written communication, and organizational skills.
• Strong software and computer skills, including Microsoft Office applications.
• Negotiation skills and confidence making decisions with minimal supervision.
• Ability to manage several projects while maintaining quality and timelines.
• Working knowledge of responsibilities, skills, and abilities at the corresponding professional grade level to guide staff.
• Advanced negotiation and influencing skills, with the ability to identify and resolve issues using a flexible, adaptable approach and remain calm, assertive, and diplomatic in challenging interactions with staff and customers.
• Ability to set a positive example of professionalism, attitude, and interactions with colleagues and customers.
• Understanding of Corporate and Global Regulatory Affairs business strategies and ability to communicate and promote them positively to staff.
• Ability to provide fair, timely, appropriate, and constructive feedback and guidance to staff.
• Ability to earn staff trust and handle personnel issues, expectations, and conflict sensitively and confidentially.
• Confidence and appropriate communication skills to represent staff concerns to senior management.
• Ability to manage competing priorities.
• Ability to communicate effectively and confidently across organizational levels and remain motivated and enthusiastic during change and pressure situations.
• Practical knowledge of leading and managing the execution of processes, projects, and tactics within one department or multiple related departments.
• Ability to exercise independent judgment and take calculated risks when making decisions.
• Applicable certifications and licenses as required by country, state, or other regulatory bodies.

Responsibilities

• Manage staff in accordance with organizational policies and applicable regulations, including assigning and directing work, appraising performance, supporting professional development, handling employee relations, and approving human resources actions such as salary administration.
• Handle personnel issues and conflict management independently, define staff goals and expectations, and support the development of staff knowledge and skills.
• Assist in coordinating projects and resources to ensure quality deliverables for customers.
• Contribute to regional business-strategy discussions as appropriate, set and implement site-specific objectives, and ensure staff understand regional and global objectives.
• Manage financial accountability for one or more Regulatory Affairs sites when assigned; undertake business development activities and monitor growth and performance as required.
• Undertake risk analysis and manage outcomes as appropriate.
• Build strong relationships with managers in other operations and represent Regulatory Affairs positively.
• Act as project manager for large standalone programs involving multiple regulatory or technical deliverables, regions, or operations, and provide strategic regulatory or technical consultancy as appropriate.
• Manage meetings with Regulatory Agencies as appropriate.
• Write or review complete single-service regulatory proposals and defend costs and timelines to clients as appropriate.
• Plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications as appropriate.
• Lead moderate to significant process, system, or product improvements to enhance performance in the job area.
• Review or approve Regulatory or cross-functional standard operating procedures when assigned.
• Support global regulatory or technical initiatives or serve as a regional representative on cross-functional initiatives.
• Perform other duties as business needs require.

Benefits

• Health and welfare benefits may be offered.
• Incentive plans, bonuses, or other forms of compensation may be offered depending on the position.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior