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Regulatory Affairs Director - São Paulo / SP

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Área de AtuaçãoDiversos / Outros

O que você irá fazer

Job Description: We are seeking a forward-thinking and metrics-driven leader to head our Regulatory Affairs department.
The ideal candidate will have experience in study start-up, served as a Department Head, and possess cross-functional and strategic expertise.
This role involves managing a team of 8-10 direct reports and requires strong financial acumen to drive success.
This position plays a crucial role in the development of regulatory business, aligning with Global Regulatory Affairs business plans.
The successful candidate will participate in project-related work as necessary and demonstrate exceptional leadership skills.
Key Responsibilities: Manage staff according to organization policies and applicable regulations; Plan, assign, and direct work; appraise performance and guide professional development; Reward and discipline employees; address employee relations issues and resolve problems; Approve actions on human resources matters, including salary administration; Essential Functions: Independently handle personnel issues, conflict management, define goals that increase knowledge and skills of staff, and define staff expectations without involvement of senior managers; Assist in the coordination of projects and resources, ensuring quality deliverables to customers; Contribute to discussions on implementation of business strategy on a regional basis and set site-specific objectives as appropriate; Ensure staff have a consistent understanding and positive impression of strategy for regional and global objectives; May have financial responsibility and accountability for one or more Regulatory Affairs sites; Undertake business development activities and monitor growth and performance as required; May undertake risk analysis and manage the outcome as appropriate; Build strong relationships with managers of other operations and act as a positive ambassador for Regulatory Affairs; May act as a Project Manager for a large stand-alone programme involving several regulatory or technical deliverables and/or region, and/or operation; May provide strategic regulatory and/or technical consultancy on a variety of projects; May manage meetings with Regulatory Agencies; May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients; May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications; Responsible for leading moderate to significant improvements of processes, systems, or products to enhance performance of job area; Problems faced are difficult and moderately complex, requiring detailed information gathering, analysis, and investigation to understand; May be assigned as Reviewer and/or Approver for Regulatory standard operating procedures or cross-functional standard operating procedures owned by other operations; May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative; Perform other duties as business needs require.
Qualifications: Bachelor''s Degree in Lifescience or related discipline (or equivalent); Master''s Degree in Lifescience or related discipline; At least 6 years regulatory experience, including 3 years management experience (or combination of education, training, and experience); Possesses specific regulatory or technical expertise; Good, solid interpersonal communication (oral and written) and organization skills; Strong software and computer skills, including Microsoft Office applications; Demonstrates negotiation skills and is confident in making decisions with minimal supervision; Ability to work on several projects, retaining quality and timelines; Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills, and abilities, as required for guidance of staff; Demonstrate success in leading teams or previous experience in a supervisory capacity; Advanced negotiating and influencing skills and ability to identify and resolve issues, using flexible adaptable approach; Sets a positive example to staff, relating to professionalism, attitude, and interaction with colleagues and customers; Understands and promotes Corporate and Global Regulatory Affairs Business Unit strategies, communicating this in a positive manner to staff; Ability to provide fair, timely, appropriate, and constructive feedback and guidance to staff; Ability to earn trust of staff, acting in confidence and with sensitivity when dealing with personnel issues, staff expectations, and conflict management; Demonstrates confidence and appropriate communication style in representing staff issues or concerns to senior management; 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 staff development, engagement, and performance; Ability to manage competing priorities, as appropriate; Advanced negotiating and influencing skills and ability to identify and resolve issues, using flexible adaptable approach; Sets a positive example to more junior staff, relating to professionalism, positive attitude, and communication style to customers and colleagues; Remains motivated and enthusiastic in times of change and other pressure situations; Possess practical knowledge in leading and managing the execution of processes, projects, and tactics within one department or multiple related departments; Ability to exercise independent judgment, taking calculated risks when making decisions; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies; Benefits: We offer a comprehensive benefits package, including health insurance, retirement savings plan, paid time off, and opportunities for career growth and development.
Others: IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
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Regulatory Affairs Director - São Paulo / SP

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