Associate Director, Regulatory Affairs

IQVIA; São Paulo; Presencial; BRL 160.000 - 200.000; Tempo integral

Resumo da oferta

A leading global provider of clinical research services is seeking a metrics-driven leader with regulatory experience. This role involves managing a team and overseeing regulatory affairs projects, ensuring quality deliverables and strategic alignment with business goals.

Qualificações

• At least 6 years regulatory experience including 3 years management experience.
• Demonstrates confidence and appropriate communication style in representing staff issues.
• Possesses specific regulatory or technical expertise.

Responsabilidades

• Manage staff in accordance with organization’s policies and applicable regulations.
• May act as a Project Manager for large programmes involving regulatory deliverables.
• Responsible for leading improvements of processes, systems or products.

Conhecimentos

Interpersonal Communication

Negotiation

Decision Making

Formação académica

Bachelor's Degree in Lifescience

Master's Degree in Lifescience

Ferramentas

Microsoft Office

Descrição da oferta de emprego

We are seeking a forward-thinking, metrics-driven leader with study start-up experience, who has served as a Department Head and possesses cross-functional and strategic expertise. This role involves managing 8-10 direct reports and requires strong financial acumen to drive success.

Job Overview

Line management responsibilities for a team of Regulatory staff or oversight of one or more Regulatory Affairs sites. Responsible for developing regulatory business aligned with Global Regulatory Affairs plans. Participates in project-related work as necessary.

Essential Functions

1. Manage staff according to organizational policies and regulations; responsibilities include planning, assigning, directing work, performance appraisal, professional development, rewards, discipline, employee relations, and HR actions such as salary administration.
2. Handle personnel issues independently, manage conflict, set staff development goals, and define expectations without senior management involvement.
3. Coordinate projects and resources, ensuring quality deliverables.
4. Contribute to regional business strategy discussions and set site-specific objectives, ensuring staff understand and align with regional and global strategies.
5. Possibly have financial responsibility for Regulatory Affairs sites, monitor growth and performance, and undertake business development activities.
6. Conduct risk analyses and manage outcomes appropriately.
7. Build strong relationships with other operational managers and act as a positive ambassador for Regulatory Affairs.
8. Potentially act as Project Manager for large programs involving multiple regulatory or technical deliverables across regions or operations.
9. Manage meetings with Regulatory Agencies.
10. Write and review regulatory proposals, defend costs and timelines to clients.
11. Plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications.
12. Lead process, system, or product improvements to enhance performance.
13. Address complex problems requiring detailed analysis and investigation.
14. Review and approve regulatory standard operating procedures or cross-functional procedures.
15. Support global regulatory initiatives or serve as regional representative in cross-functional projects.
16. Perform other duties as needed.

Qualifications

• Bachelor's Degree in Life Sciences or related discipline (required), or Master's Degree (preferred).
• At least 6 years of regulatory experience, including 3 years in management, or equivalent combination of education, training, and experience.
• Specific regulatory or technical expertise.
• Strong interpersonal, communication, and organizational skills.
• Proficiency in Microsoft Office and other relevant software.
• Negotiation skills, decision-making confidence, and ability to manage multiple projects.
• Experience in leading teams, staff development, and engagement.
• Advanced influencing skills, problem-solving ability, and composure in challenging interactions.
• Ability to provide constructive feedback, earn staff trust, and handle personnel issues sensitively.
• Line management experience with a proven track record of staff performance management.
• Ability to manage priorities and exercise independent judgment.
• Relevant certifications and licenses as required by 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