Senior Regulatory Affairs Consultant at Parexel

Job Description

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.