Senior Regulatory Affairs Consultant

PAREXEL; Teletrabalho; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

A global clinical research company is looking for a Senior Consultant responsible for overseeing end-to-end labeling development and implementation across various markets. The role includes ensuring compliance with regulatory requirements and managing operational processes. Ideal candidates should have a Bachelor's degree in a scientific field and possess high-level consulting skills along with strong interpersonal communication abilities, critical thinking, and project management experience.

Responsabilidades

• Oversee end-to-end labeling development and implementation for Foundational markets.
• Ensure compliance with country-specific regulatory requirements.
• Manage operational processes for artwork creation, translation, and implementation.
• Act as key partner to GRA Regions, Regulatory CMC, and supply chain.

Conhecimentos

High-level consulting skills

Critical thinking and problem-solving

Project leadership and management

Excellent interpersonal and intercultural communication

Client-focused approach

Results orientation

Teamwork and collaboration

Proficiency in local language and English

Networking

Business analysis

Self-confidence and control

Formação académica

Bachelor’s degree in a Scientific or Technical Discipline

Advanced Degree preferred

Descrição da oferta de emprego

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Senior Consultant is responsible for overseeing end-to-end labeling development and implementation across Foundational markets (US, EU, CH, DE, AU) and non-US/Central EU regions. This role ensures compliance with country-specific regulatory requirements and manages operational processes for artwork creation, translation, and implementation. Acting as a key partner to Global Regulatory Affairs (GRA) Regions, Regulatory CMC, and Supply Chain, the Senior Consultant provides strategic guidance and operational leadership to support global labeling initiatives.

Key Accountabilities

Oversees end-to-end labeling development and implementation for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets.

Key Responsibilities

Ensure compliance with country-specific regulatory requirements.

Manage operational processes for artwork creation, translation, and implementation.

Act as key partner to GRA Regions, Regulatory CMC, and supply chain.

Skills

• High-level consulting skills.
• Critical thinking and problem-solving skills.
• Project leadership and management knowledge.
• Excellent interpersonal and intercultural communication skills, both written and verbal.
• Client-focused approach to work.
• Results orientation.
• Teamwork and collaboration skills.
• Proficiency in local language and extensive working knowledge of the English language.
• Networking.
• Business analysis.
• Self-confidence and control.

Education

• Minimum of a bachelor’s degree in a Scientific or Technical Discipline, Advanced Degree preferred.