⏳ Last Date to Apply: Not Specified
Parexel Regulatory Submissions Coordinator (Biological products) Recruitment 2026: Apply Online
Regulatory Submissions Coordinator (Biological products)
Job Overview
As part of Parexel Consulting, the Regulatory Submissions Coordinator plays a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
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 Responsibles (LRRs), Regulatory Partner Representatives (RPRs), and cross-functional stakeholders.
This is a fully remote position based in either Mexico or Argentina, offering a highly collaborative, innovative, and continuous learning environment. You will partner with a diverse group of clients and be exposed to various product types and therapeutic areas, developing your skills through challenging assignments and mentorship from experienced regulatory professionals.
Key Job Details
| Company Name | Parexel |
| Job Role | Regulatory Submissions Coordinator (Biological products) |
| Experience | Associate: 1–3 years | Sr Associate: 3+ years |
| Salary Range | Not Specified |
| Job Type | Full-Time |
| Work Mode | Remote |
| Openings | Not Specified |
| Job Location | Mexico / Argentina (Remote) |
Key Responsibilities
- Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) activities in accordance with defined submission strategies.
- Assist in organizing submission team meetings, including 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.
- 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 and track print releases.
- Support change control activities related to local labeling updates and ensure appropriate archiving of labeling documentation in DocNet.
- Support the creation, maintenance, and accuracy of submission and regulatory records in regulatory systems like Veeva RIMS and Apollo.
- Perform assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements.
Requirements & Qualifications
- Experience with Biological Products is mandatory.
- Experience with regulatory submission processes and lifecycle management activities in LATAM.
- Experience with Veeva RIM and document management tools.
- Effective written and verbal communication skills in English and Spanish (mandatory).
- Must be based in Mexico or Argentina.
- Strong organizational skills with attention to detail and quality.
- Ability to manage multiple tasks and timelines in a matrix environment.
Required Skills
- Veeva RIM & Document Management
- LATAM Regulatory Frameworks
- Biological Products Lifecycle Management
- Bilingual Communication (English & Spanish)
- Cross-functional Collaboration
- Detail-oriented Project Tracking
- SOP Compliance & Quality Assurance
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.
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