Job Description
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...