Sr Start-up & Regulatory Specialist (Ciudad de México)

Sr Start-up & Regulatory Specialist (Ciudad de México)

01 ago
|
Fortrea
|
Ciudad de México

01 ago

Fortrea

Ciudad de México

**Be the Catalyst for Clinical Trial Activation**
Drive the momentum of vital clinical trials as the primary contact for investigative sites in a integral perspective (focused on North America projects). Your expertise in local/regional regulations will ensure swift and compliant start-up, working with diverse stakeholders to bring innovative treatments closer to patients.
**Your Impact**:
- Own the collection and quality review of essential study documents.
- Navigate IRB/EC/Regulatory Authority submissions with confidence.
- Proactively anticipate and resolve start-up hurdles, ensuring timelines are met.
- Mentor and guide team members, sharing your regulatory mastery.
- Liaise with clients and internal teams, providing expert insights.




- Contribute to best practices and process optimization within the region.
**Your Expertise**:
- 5+ years in clinical research start-up projects and keen expertise on regulatory affairs with deep ICH-GCP and local regulation knowledge.
- Proven ability to manage site start-up activities and documentation.
- Strong communication, negotiation, and problem-solving skills.
- Experience collaborating with investigative sites and project teams.
- Fluency in English and the local language.
Learn more about our EEO & Accommodations request here.

📌 Sr Start-up & Regulatory Specialist (Ciudad de México)
🏢 Fortrea
📍 Ciudad de México

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