Regulatory Submissions Coordinator, Biological Products

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

📋 Description

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

• Help organize meetings for submission teams.

• Coordinate, request, and monitor documentation from Subject Matter Experts (SMEs).

• Aid in the preparation and upkeep of the Submission Content Plan (SCP).

• Ensure prompt dispatch of non-eCTD submission packages.

• Provide direct operational support for labeling activities.

• Prepare annotated labeling documents for regulatory review purposes.

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

• Monitor print releases as necessary.

• Support change control activities related to local labeling updates.

• Ensure proper archiving of labeling documentation.

• Assist in creating, maintaining, and ensuring accuracy in submission and regulatory records within regulatory systems.

• Upload Module 1 and non-eCTD submission documents to DocNet.

• Update regulatory systems with interactions from Health Authorities.

• Provide regular status updates to the Regional Submission Coordinator (Lead).

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

• Collaborate efficiently with cross-functional teams.

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

⛳️ Requirements

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

• Associate: 1–3 years of experience; Sr Associate: over 3 years in regulatory affairs, regulatory operations, or a related pharmaceutical/biotechnology position.

• Experience with Biological Products (mandatory).

• Familiarity with regulatory submission processes and lifecycle management activities.

• Proficiency in Veeva RIM and document management systems.

• Strong written and verbal communication skills in both English and Spanish (mandatory).

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

• Ability to juggle multiple tasks and deadlines in a matrix environment.

🏝️ Benefits

• Health insurance.

• 401(k).

• Flexible work arrangements.

• Paid time off.

• Professional development.