Regulatory Submissions Coordinator (Biological products)

About Parexel

Parexel is a leading clinical research organization providing comprehensive services to the pharmaceutical, biotechnology, and medical device industries. We are committed to advancing clinical research and bringing innovative therapies to patients worldwide. Our diverse team of professionals is dedicated to delivering excellence in regulatory affairs, clinical operations, and data management.

Regulatory Submission Coordinator – Sr Associate

About the Role

Join Parexel's Regulatory Affairs team as a Regulatory Submission Coordinator and play a critical role in bringing innovative biological products to patients across Latin America. Reporting to the Regional Submission Coordinator Lead, you'll be the operational backbone of our regulatory submission process—coordinating complex documentation, managing timelines, and ensuring compliance across multiple countries in the LATAM region.

This is an opportunity to work at the heart of regulatory excellence, collaborating with regional regulatory teams, health authorities, and cross-functional stakeholders to deliver high-quality submissions that meet the highest standards.

The Opportunity

Sr Associate Level: 4+ years of regulatory experience

What You'll Do

Submission Coordination & Operational Support

• Coordinate and support the preparation and delivery of regulatory submissions and lifecycle management activities across assigned LATAM countries
• Organize and facilitate submission team meetings (Kick-off Meetings, etc.) and track action items
• Request, coordinate, and track documentation from Subject Matter Experts to ensure submission readiness
• Prepare and maintain Submission Content Plans under guidance of the RSC Lead
• Ensure timely dispatch of submission packages to Local Regulatory Representatives and Regulatory Partner Representatives

Labeling Operational Support

• Execute hands-on labeling activities, including preparation of annotated documents for regulatory review
• Initiate and coordinate mock-up requests in the Artwork Management System
• Track print releases and support change control activities for local labeling updates
• Archive labeling documentation and ensure approved labeling is accurately stored in DocNet

Regulatory Systems & Documentation

• Create, maintain, and ensure accuracy of submission records in regulatory systems (Veeva RIMS, Apollo)
• Upload Module 1 and non-eCTD documents to DocNet with full traceability
• Update regulatory systems with Health Authority interactions and regulatory correspondence
• Maintain data quality and consistency across systems and repositories

Project Support & Communication

• Provide regular status updates on assigned activities, timelines, and potential issues
• Track submission milestones, deliverables, and dependencies
• Escalate operational issues with context and proposed mitigation actions
• Collaborate effectively with CMC, labeling, quality, and regulatory teams

Quality & Compliance

• Execute all activities in compliance with SOPs, work instructions, and regional regulatory requirements
• Support inspection readiness through accurate, complete, and well-organized documentation
• Maintain awareness of regional regulatory processes and follow guidance from the RSC Lead and Regional Regulatory Leads

What We're Looking For

Mandatory Requirements:

• Bachelor's degree in Life Sciences, Pharmacy, or related discipline
• Experience with Biological Products (required)
• Experience with regulatory submission processes and lifecycle management activities in LATAM
• Proficiency with Veeva RIM and document management tools (required)
• Fluent written and verbal communication in English
• Based in Mexico or Argentina (required)

Key Competencies:

• Strong organizational skills with meticulous attention to detail
• Ability to manage multiple tasks and timelines in a matrix environment
• Proactive problem-solver with strong communication skills
• Collaborative team player with cross-functional experience
• Detail-oriented with a commitment to quality and compliance

Why Join Parexel?

• Impact: Contribute directly to bringing innovative biological therapies to patients across Latin America
• Growth: Work with a leading CRO and develop expertise in regulatory affairs and submission management
• Collaboration: Partner with talented regulatory professionals and cross-functional teams
• Development: Access professional development and career advancement opportunities
• Culture: Join a diverse, inclusive team committed to excellence in clinical research
• Competitive Package: Competitive compensation and comprehensive benefits

Equal Opportunity

Parexel is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected characteristic.