Regulatory Submission Coordinator

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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.

Regional Submission Coordinator – Associate

Position Overview

The Regional Submission Coordinator – Associate - supports the execution and coordination of regulatory submission and labeling activities across assigned countries within a region. Reporting to the Regional Submission Coordinator (Lead), this role focuses on operational delivery, documentation coordination, system updates, and labeling execution to ensure timely, compliant, and high-quality regulatory submissions. The Associate works in close collaboration with the Lead, Regional Regulatory Leads (RRLs), Local Regulatory Responsibles (LRRs), Regulatory Partner Representatives (RPRs), and cross-functional stakeholders.

Key Responsibilities – Submission Coordination & Operational Support

• Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) activities in accordance with submission strategies defined by the RRL and coordinated by the Regional Submission Coordinator (Lead).
• Assist in organizing submission team meetings (e.g., Kick-off Meetings) and follow up on agreed actions.
• Coordinate, request, and track documentation from Subject Matter Experts (SMEs) to support submission readiness and timelines.
• Support the preparation and maintenance of the Submission Content Plan (SCP) under the guidance of the RSC Lead.
• Ensure timely dispatch of non-eCTD submission packages to LRRs and RPRs and track dispatched documentation per country.

Key Responsibilities – Labeling Operational Support

• Provide hands-on operational support for labeling activities, performing assigned tasks under the guidance of the RSC Lead.
• Prepare annotated labeling documents for regulatory review in collaboration with RRLs, LRRs, and RPRs.
• Initiate and coordinate mock-up requests in the Artwork Management System.

• Track print releases as required.

• Support change control activities related to local labeling updates.
• Ensure appropriate archiving of labeling documentation and that approved labeling is accurately and timely stored in DocNet.

Key Responsibilities – Regulatory Systems & Documentation

• Support the creation, maintenance, and accuracy of submission and regulatory records in regulatory systems (e.g., Veeva RIMS, Apollo).
• Upload Module 1 and non-eCTD submission documents to DocNet and ensure completeness and traceability.
• Update regulatory systems with Health Authority interactions, including uploading questions received from Health Authorities in the appropriate records.
• Support data quality and consistency across systems and documentation repositories.

Project Support & Communication

• Provide regular status updates to the Regional Submission Coordinator (Lead) on assigned activities, timelines, and potential issues.
• Support tracking of submission milestones, deliverables, and dependencies.
• Escalate operational issues or delays to the RSC Lead with appropriate context and proposed mitigation actions.
• Collaborate effectively with cross-functional teams including CMC, labeling, quality, and regulatory stakeholders.

Quality & Compliance

• Perform assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements.
• Support inspection readiness by ensuring accurate, complete, and well-organized submission and labeling documentation.
• Maintain awareness of regional regulatory processes relevant to assigned activities and follow guidance provided by the Lead and RRLs.

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.
• 1–3 years of experience in regulatory affairs, regulatory operations, or a related pharmaceutical/biotechnology role.
• Good understanding of regulatory submission processes and lifecycle management activities.
• Experience or familiarity with regulatory information management systems (e.g., Veeva RIMS) and document management tools.
• Strong organizational skills with attention to detail and quality.
• Ability to manage multiple tasks and timelines in a matrix environment.
• Effective written and verbal communication skills in English and Spanish (mandatory)

Key Competencies

Technical Competencies:

• Regulatory submission documentation and coordination
• Labeling operational support and artwork coordination

• Regulatory systems and data management

Professional & Behavioral Competencies:

• Attention to detail and quality orientation
• Strong organizational and follow-up skills
• Collaborative mindset and stakeholder support
• Adaptability in a fast-paced, cross-regional environment
• Team-oriented approach with a service mindset