[Hiring] Regulatory Affairs - Marketing Authorization Application @Parexel

Role Description

We are seeking a Regulatory Affairs professional, with strong experience in dossier management, registration applications, and interactions with INVIMA and other LATAM Health Authorities. Are you a regulatory professional with strong knowledge of the Colombian regulatory environment and experience supporting the registration and lifecycle management of pharmaceutical products? Join our team and play a key role in delivering regulatory excellence across Colombia while collaborating with regional and global stakeholders.

Key Responsibilities

• 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.

Qualifications

• 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. Please indicate the countries supported and the level of regulatory responsibility held in each market.
• Excellent verbal and written communication skills in both English and Spanish.

What We Are Looking For

The ideal candidate is a proactive and detail-oriented regulatory professional who can independently manage complex regulatory activities in Colombia, collaborate effectively with diverse stakeholders, and balance operational execution with regulatory insight. This individual demonstrates strong ownership, anticipates challenges, and contributes to the successful delivery of regulatory objectives in a fast-paced environment.