Regulatory Submission Coordinator

📋 Description

• Assist in the coordination, preparation, and execution of regulatory submissions and lifecycle management (LCM) tasks.

• Help organize submission team meetings (such as Kick-off Meetings) and ensure follow-up on assigned actions.

• Coordinate, request, and monitor documentation from Subject Matter Experts (SMEs) to facilitate submission readiness and timelines.

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

• Ensure the timely delivery of non-eCTD submission packages to Local Regulatory Representatives (LRRs) and Regulatory Project Representatives (RPRs), and track sent documents by country.

• Provide practical operational support for labeling tasks.

• Create annotated labeling documents for regulatory assessment.

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

• Assist with change control processes related to local labeling updates.

• Support the development, maintenance, and accuracy of submission and regulatory records within regulatory systems.

⛳️ Requirements

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

• 1–3 years of experience in regulatory affairs, regulatory operations, or a similar role within the pharmaceutical or biotechnology sectors.

• Solid 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.

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

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

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

🏝️ Benefits

• Health insurance

• Professional development opportunities