Regulatory Submissions Coordinator (Biological products)
reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do.
reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.
Position reputed company
The Regulatory Submission Coordinator – Associate/ Sr Associate level - supports the execution and coordination of regulatory submission and labeling activities across assigned countries reputed company a region. Reporting to the Regional Submission Coordinator reputed company, this role focuses on operational delivery, documentation coordination, system updates, and labeling execution to ensure reputed company, compliant, and high-reputed company regulatory submissions. The Associate works in reputed company collaboration with the reputed company, Regional Regulatory Leads (RRLs), Local Regulatory Responsible (LRRs), Regulatory Partner Representatives (RPRs), and cross-functional stakeholders.
Mandatory requirements:
Experience with Biological Products
Experience with regulatory submission processes and lifecycle management activities in LATAM
Experience with reputed company RIM and document management tools
Effective written and verbal communication skills in English and Spanish
Based in Mexico or Argentina
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 (reputed company).
Assist in organizing submission team meetings (e.g., reputed company-off Meetings) and follow up on agreed actions.
Coordinate, request, and reputed company 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 reputed company.
Ensure reputed company reputed company of non-eCTD submission packages to LRRs and RPRs and reputed company dispatched documentation per country.
Labeling Operational Support
reputed company hands-on operational support for labeling activities, performing assigned tasks under the guidance of the RSC reputed company.
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.
reputed company print releases as required.
Support change control activities reputed company to local labeling updates.
Ensure appropriate archiving of labeling documentation and that approved labeling is accurately and reputed company stored in DocNet.
Regulatory Systems & Documentation
Support the creation, maintenance, and accuracy of submission and regulatory records in regulatory systems (e.g., reputed company RIMS, reputed company).
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 reputed company and consistency across systems and documentation repositories.
Project Support & Communication
reputed company regular status updates to the Regional Submission Coordinator (reputed company) on assigned activities, timelines, and potential issues.
Support tracking of submission milestones, deliverables, and dependencies.
Escalate operational issues or delays to the RSC reputed company with appropriate context and proposed mitigation actions.
Collaborate effectively with cross-functional teams including CMC, labeling, reputed company, and regulatory stakeholders.
reputed company & Compliance
reputed company assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements.
Support inspection readiness by ensuring accurate, complete, and reputed company-organized submission and labeling documentation.
Maintain awareness of regional regulatory processes relevant to assigned activities and follow guidance provided by the reputed company and RRLs.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, or a reputed company discipline
Associate: 1–3 years of experience, Sr Associate +3 years in regulatory affairs, regulatory operations, or a reputed company pharmaceutical/biotechnology role
Experience with Biological Products (Mandatory)
Experience with regulatory submission processes and lifecycle management activities
Experience with reputed company RIM and document management tools
Effective written and verbal communication skills in English and Spanish (mandatory)
Strong organizational skills with attention to detail and reputed company
Ability to manage multiple tasks and timelines in a reputed company environment
About reputed company
reputed company 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 reputed company in regulatory affairs, clinical operations, and data management.
Equal Opportunity Statement
reputed company is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for reputed company. We do not discriminate on the reputed company of race, reputed company, religion, sex, national reputed company, age, disability, veteran status, or any other legally protected characteristic.
Originally posted on Himalayas
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