The specialist ensures compliance with all regulatory requirements for the assigned product portfolio according to Organon policies in Colombia
Job Summary
The specialist ensures compliance with all regulatory requirements for the assigned product portfolio according to Organon policies in Colombia.
This role serves as the primary contact for local stakeholders and headquarters regarding specific submissions to health authorities.
The position involves collaborating with colleagues to maintain adherence to local laws and adjust schedules to prevent interruptions in adverse event reporting.
Matching Summary
The specialist ensures compliance with all regulatory requirements for the assigned product portfolio according to Organon policies in Colombia.
Skills & Requirements
Must-have
3 to 5 years regulatory affairs experience
Pharmaceutical industry background
ICH GMP and local regulations knowledge
Advanced English proficiency
MS Office software mastery
Nice-to-have
Postgraduate degree in pharmacy
Strong communication skills
Creative initiative and flexibility
Team collaboration abilities
Time management expertise
Key Requirements
Degree in Pharmaceutical Chemistry (Químico Farmacéutico)