Regulatory Affairs Director

beBee Careers; São Paulo; Presencial; BRL 150.000 - 200.000; Tempo integral

Resumo da oferta

A leading company in clinical research seeks a Director of Regulatory Strategy to lead their Regulatory Affairs department. The successful candidate will manage a team, drive regulatory business development, and ensure alignment with global objectives. This role requires strong leadership, financial acumen, and the ability to navigate complex regulatory environments. A comprehensive benefits package is offered, including health insurance and opportunities for career growth.

Serviços

Health Insurance

Retirement Savings Plan

Paid Time Off

Opportunities for Career Growth

Qualificações

• At least 6 years regulatory experience, including 3 years management experience.
• Possesses specific regulatory or technical expertise.

Responsabilidades

• Manage staff according to organization policies and applicable regulations.
• Plan, assign, and direct work; appraise performance and guide professional development.

Conhecimentos

Interpersonal Communication

Negotiation

Leadership

Formação académica

Bachelor's Degree in Lifescience

Master's Degree in Lifescience

Ferramentas

Microsoft Office

Descrição da oferta de emprego

Job Title: Director of Regulatory Strategy

Salary:

The successful candidate will receive a highly competitive salary package.

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.