Regulatory Submission Coordinator

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Assist in the coordination, preparation, and submission of regulatory documents and lifecycle management (LCM) tasks in alignment with submission strategies outlined by the RRL and managed by the Regional Submission Coordinator (Lead).

• Help organize meetings for the submission team (such as Kick-off Meetings) and follow up on agreed-upon action items.

• Facilitate the coordination, request, and tracking of documentation from Subject Matter Experts (SMEs) to ensure submission readiness and adherence to timelines.

• Aid in the preparation and upkeep of the Submission Content Plan (SCP) under the supervision of the RSC Lead.

• Ensure the timely distribution of non-eCTD submission packages to LRRs and RPRs, and monitor the dispatched documentation for each country.

• Provide direct operational support for labeling tasks, executing assigned responsibilities under the direction of the RSC Lead.

• Create annotated labeling documents for regulatory review in collaboration with RRLs, LRRs, and RPRs.

• Initiate and manage mock-up requests within the Artwork Management System.

• Monitor print releases as necessary.

• Assist with change control procedures related to local labeling modifications.

• Ensure proper archiving of labeling documents and timely storage of approved labeling in DocNet.

• Aid in the development, maintenance, and accuracy of submission and regulatory records in regulatory systems (e.g., Veeva RIMS, Apollo).

• Upload Module 1 and non-eCTD submission materials to DocNet while ensuring their completeness and traceability.

• Update regulatory systems with interactions from Health Authorities, including recording questions received from them in the appropriate documentation.

• Promote data quality and consistency across various systems and documentation repositories.

• Provide regular updates to the Regional Submission Coordinator (Lead) regarding assigned tasks, timelines, and any potential issues.

• Support the tracking of submission milestones, deliverables, and dependencies.

• Report operational challenges or delays to the RSC Lead, providing necessary context and suggested mitigation strategies.

• Collaborate effectively with cross-functional teams, including CMC, labeling, quality, and regulatory stakeholders.

• Execute assigned tasks in accordance with applicable SOPs, work instructions, and regional regulatory standards.

• Contribute to inspection readiness by ensuring submission and labeling documentation is accurate, complete, and well-organized.

• Stay informed about regional regulatory procedures pertinent to assigned tasks and adhere to the guidance provided by the Lead and RRLs.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or a related field.

• 1–3 years of experience in regulatory affairs, regulatory operations, or a comparable role in the pharmaceutical/biotechnology sector.

• Solid understanding of regulatory submission processes and lifecycle management tasks.

• Experience or familiarity with regulatory information management systems (e.g., Veeva RIMS) and document management software.

• Excellent organizational abilities with a strong focus on detail and quality.

• Capability to manage multiple tasks and deadlines within a matrix organizational environment.

• Proficient written and verbal communication skills in both English and Spanish (required).

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development