Assoc Regulatory Affairs Spec (Bogotá)

Location and Work Model

This position will be based in Colombia, Bogotá, in a hybrid work model.

Responsibilities

• Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
• Lead or compile all materials required in submissions, license renewal and annual registrations
• Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
• Monitor and improve tracking / control systems
• Keep abreast of regulatory procedures and changes
• May direct interaction with regulatory agencies on defined matters
• Recommend strategies for earliest possible approvals of clinical trials applications

Required Knowledge and Experience

• Bachelor’s degree in Pharmaceutical Chemistry, Biomedical Engineering, Medicine, Chemical Engineering, or related field, and/or p...