Regulatory Affairs Specialist

Ensure that the product portfolio under their responsibility complies with all regulatory requirements for updating inserts and monographs, and that any change or update to them is duly approved by the authorities and implemented by the company within the timeframes defined in the regulations.

Prepare product dossiers for submission to health authorities via regular procedure and abbreviated procedure.

General standards on labeling and packaging.

Renewal of Operating Licenses before the DNFD for the companies assigned to them.

Requisitos

• Bachelor's degree in Pharmacy with professional licensure (indispensable)
• Experience in regulatory affairs or drug terminologies minimum one (1) year.
• Basic product formulation.
• Intermediate English proficiency for documentation.

Competencias:

• Proactivity and organization
• Analytical and synthesis capacity
• Good communication

Ofrecemos

• Competitive salary according to the market.
• Training and Coaching.
• Life and Medical Insurance.

-Requerimientos-

Minimum education: University 2 years of experience

Keywords: specialist, especialista