Regulatory Submissions Coordinator

Responsibilities

• Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management activities for biological products.
• Assist in organizing submission team meetings and following up on agreed actions.
• Coordinate and track documentation from Subject Matter Experts (SMEs) to ensure submission readiness.
• Provide operational support for labeling activities, including preparing annotated documents and coordinating mock-up requests.
• Maintain and update regulatory records in systems such as Veeva RIM and Apollo.
• Ensure compliance with applicable SOPs, work instructions, and regional regulatory requirements.
• Collaborate with cross-functional teams including CMC, labeling, quality, and regulatory stakeholders.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or a related discipline.
• Experience with Biological Products (Mandatory).
• Experience with regulatory submission processes and lifecycle management activities in LATAM.
• Experience with Veeva RIM and document management tools.
• Fluency in both English and Spanish (written and verbal).
• Must be based in Mexico or Argentina.
• 1–3 years of experience for Associate level; 3+ years for Senior Associate level in regulatory affairs or related roles.

About the Company

Parexel 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 through expertise, empathy, and a patient-led approach.