Position Overview

The Regulatory Submission Coordinator – Associate/ Sr Associate level - 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 Responsible (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.

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.

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
• Associate: 1–3 years of experience, Sr Associate +3 years in regulatory affairs, regulatory operations, or a related pharmaceutical/biotechnology role
• Experience with Biological Products (Mandatory)
• Good understanding of regulatory submission processes and lifecycle management activities
• Experience with Veeva RIM 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)

About Parexel

Parexel is a leading clinical research organization (CRO) 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.

Equal Opportunity Statement

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.