Regulatory Affairs - Marketing Authorization Application (Colombia)

Parexel; Medellín; Remote; COP 120,000,000 - 180,000,000; Full time

Job summary

Parexel is seeking a Regulatory Affairs professional to lead dossier management, registrations, and interactions with INVIMA for LATAM products, working remotely from Colombia.

The ideal candidate will have 5+ years of Regulatory Affairs experience, deep knowledge of Colombia's regulatory framework, and fluency in English and Spanish. Responsibilities include cross-functional collaboration and lifecycle management across regulatory submissions and health authority inquiries.

Qualifications

• Minimum of 5 years of progressive Regulatory Affairs experience.
• Proven regulatory experience supporting products in Colombia.
• Strong knowledge of the Colombian regulatory framework and INVIMA requirements for biologics and synthetic products.
• Familiarity with INVIMA submission pathways and electronic submission processes is highly preferred.
• Experience preparing and managing regulatory submissions, amendments, renewals, and responses to health authority questions.
• Excellent verbal and written communication in English and Spanish.

Responsibilities

• Prepare, compile, review, and submit regulatory applications and supporting documentation to INVIMA, including 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 dossier completeness and quality.
• Monitor regulatory developments and communicate relevant changes that impact products or activities.

Skills

Regulatory affairs

INVIMA knowledge

Colombia regulatory framework

CTD structure

Cross-functional collaboration

Job description

When our values align, there's no limit to what we can achieve.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).

About the role

We are seeking a Regulatory Affairs professional, with strong experience in dossier management, registration applications, and interactions with INVIMA and other LATAM Health Authorities to work remotely from Colombia (mandatory)

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 escalat... strategic or authority-sensitive matters as needed.

Qualifications and Experience

• 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.