Regulatory Affairs – Marketing Authorization Application, Colombia

Job not on LinkedIn

🔥 2 hours ago

🇨🇴 Colombia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Prepare, compile, review, and submit regulatory applications and supporting documentation to INVIMA, including new registrations, variations, renewals, supplements, amendments, and responses to health authority requests • Manage regulatory lifecycle activities for assigned products, ensuring compliance with local regulatory requirements and timelines • Support regulatory strategy implementation and operational execution for products registered in Colombia • Coordinate cross-functional contributions to regulatory submissions and ensure the completeness and quality of dossiers • Maintain regulatory trackers, submission schedules, and documentation to ensure accurate status reporting and timely execution • Monitor regulatory developments and communicate relevant changes that may impact products or regulatory activities • Collaborate closely with global, regional, and local stakeholders to provide regulatory support and drive project deliverables • Identify potential regulatory risks, proactively address operational challenges, and escalate strategic or authority-sensitive matters as needed

🎯 Requirements

• Minimum of 5 years of progressive Regulatory Affairs experience within the pharmaceutical or biotechnology industry • Proven regulatory experience supporting products in Colombia • Strong knowledge of the Colombian regulatory framework and INVIMA requirements for biologics and synthetic products, including registration and lifecycle management activities • Familiarity with INVIMA submission pathways, administrative requirements, and electronic submission processes is highly preferred • Demonstrated experience preparing and managing regulatory submissions, amendments, renewals, supplements, and responses to health authority questions • Strong understanding of CTD structure, format, and content requirements • Experience authoring, reviewing, and coordinating regulatory documentation across multiple functions • Ability to successfully work in a cross-functional, matrix environment while managing multiple priorities and deadlines • Strong organizational and project management skills with a proven ability to manage regulatory timelines and deliverables • Demonstrated ability to work independently, exercise sound judgment, and take ownership of regulatory activities • Experience with vaccines, biologics, infectious diseases, or other complex products is considered an advantage • Exposure to regulatory requirements in other LATAM countries is desirable • Excellent verbal and written communication skills in both English and Spanish