Regulatory Affairs specialist

Position Summary

We are seeking a Regulatory Affairs professional to support lifecycle management (LCM) activities across LATAM, with a focus on Colombia, Ecuador, and Peru. This role is responsible for the end‑to‑end execution of post‑registration regulatory processes, ensuring timely submissions, approvals, and compliance with local regulations and internal standards.

Key Responsibilities

• Execute end‑to‑end lifecycle regulatory processes for post‑registration changes across assigned LATAM countries.
• Prepare high‑quality submission‑ready dossiers aligned with local regulatory requirements and J&J standards.
• Ensure timely assessment, submission, and approval of regulatory variations.
• Act as the primary point of contact for lifecycle regulatory activities with local RA teams.
• Manage and respond to Health Authority queries, ensuring accuracy and alignment with stakeholders.
• Coordinate cross‑functional collaboration (Regulatory Affairs, Quality, ArtWorks, and other stakeholders).
• Maintain and update Regulatory Affairs systems and databases.
• Ensure proper documentation and archiving of submissions and approvals.
• Assess impact of new regulations and support implementation plans, identifying risks and opportunities.
• Contribute to continuous improvement initiatives and knowledge sharing within the team.

Qualifications

• Education: Bachelor’s degree in Health Sciences, Biological Sciences, or a related field.
• 1 to 4 years of experience in the pharmaceutical industry (Regulatory Affairs or related areas).
• Experience in lifecycle management, including labeling and CMC variations.
• Strong understanding of regulatory submission processes and compliance (preferred).
• Ability to work in cross‑functional and regional environments.
• Proactive, detail‑oriented, and execution‑focused mindset.
• Strong analytical and problem‑solving skills with ability to work independently.
• Preferred: Experience supporting multiple LATAM markets.
• Familiarity with biological products regulations.

Language Requirements

Proficient in Spanish; Intermediate English is required.

Core Competencies

• Compliance and execution excellence.
• Collaboration and teamwork mindset.
• Adaptability to regulatory changes.
• Strong communication skills.
• Continuous improvement and innovation mindset.
• Learning agility and curiosity.

Required Skills

• Analytical Reasoning
• Brand Research
• Business Behavior
• Design Thinking
• Detail‑Oriented
• Industry Analysis
• Market Research
• Package and Labeling Regulations
• Problem Solving
• Process Oriented
• Product Packaging Design
• Project Management
• Project Support
• Proof Reading Software
• Quality Assurance (QA)
• Regulatory Affairs Management
• Regulatory Compliance
• Risk Assessments
• Safety‑Oriented

Preferred Skills

• Experience supporting multiple LATAM markets.
• Familiarity with biological products regulations.