Regulatory Submissions Associate – Biological Products

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

📋 Description

• Assist in the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) initiatives in line with submission strategies outlined by the RRL and managed by the Regional Submission Coordinator (Lead).

• Help organize submission team meetings (e.g., Kick-off Meetings) and follow up on the actions agreed upon.

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

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

• Ensure prompt dispatch of non-eCTD submission packages to LRRs and RPRs while tracking dispatched documents by country.

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

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

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

• Track print releases as necessary.

• Support change control activities related to local labeling updates.

• Ensure proper archiving of labeling documentation and that approved labeling is accurately and timely stored in DocNet.

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

• Upload Module 1 and non-eCTD submission documents to DocNet, ensuring completeness and traceability.

• Update regulatory systems with Health Authority interactions, including uploading inquiries received from Health Authorities in the relevant records.

• Support data quality and consistency across systems and documentation repositories.

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

• Assist in tracking submission milestones, deliverables, and dependencies.

• Escalate operational issues or delays to the RSC Lead with appropriate context and suggested mitigation actions.

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

• Carry out assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements.

• Aid in inspection readiness by ensuring that submission and labeling documentation is accurate, complete, and well-organized.

⛳️ 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 similar pharmaceutical/biotechnology position.

• Experience with Biological Products is mandatory.

• Strong understanding of regulatory submission processes and lifecycle management activities.

• Familiarity with Veeva RIM and document management tools.

• Excellent organizational skills with a keen eye for detail and quality.

• Ability to handle multiple tasks and timelines within a matrix environment.

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

🏝️ Benefits

• Health insurance.

• Professional development opportunities.

• Paid time off.

• Flexible working hours.