Junior Regulatory Associate (Colombia)

Job Description

We are looking for a Junior Regulatory Associate to join our expanding team.

Responsibilities

• Review and finalise Global Regulatory Strategy Documents and CTD sections for IND, CTA, BLA, NDA, and ANDA submissions to ensure effective data presentation as per guidance.
• Coordinate with cross‑functional teams, site, and global Regulatory Affairs teams for authoring, reviewing, and finalising dossiers for pipeline products to ensure effective data presentation and quality.
• Prepare quality dossiers for pipeline molecules and supplements to support product launch.
• Monitor and set timelines for filing MA transfers, variations, license renewals, product amendments/supplements, and other product life‑cycle management activities including annual reports and safety report filing.
• Collaborate with global and other regional regulatory client teams to author quality regulatory submissions for pipeline products.