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Senior Regulatory Affairs Consultant

Primary Location: Brazil, Remote Job ID R0000037323 Category Regulatory Affairs Date Posted 12/23/2025
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Overview

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

  • Communicator
  • Detail-oriented
  • Problem-solver
  • Relationship-builder
  • Results-driven
  • Strategic

About This Role

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.


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