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...