Senior Regulatory Affairs Consultant
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Job Description
Senior Consultant managing labeling development and implementation across multiple regions for Parexel. Ensuring regulatory compliance and operational process management in clinical research.
Responsibilities:
- Oversees end-to-end labeling development and implementation for Foundational (US, EU, CH, DE, AU) and non-US/Central EU 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.
Requirements:
- Minimum of a bachelor’s degree in a Scientific or Technical Discipline
- 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
Benefits:
- Health insurance
- Professional development
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