Regulatory Affairs Sr Analyst

The mision of the role Liaise between local teams and partners. Leads regulatory planning and execution across LATAM markets, review information and identify GAPs and risks of each process. Interact with various internal teams to present needs according to standards, considering and assisting in planning when they will be necessary.

Review and identify the necessary documentation for the registration, renewal and maintenance (post approval changes) of Certificates of Medicinal Specialties of products before the different authorities at the regional level, interacting with local teams and partners. Creates and maintains database.

Responsabilities:

• Act as the main point of contact/interphase for Partner & Local Key Stakeholders.
• Evaluates technical data the data (chemistry/ manufacturing, clinical) and preparation of summaries and country specific adaptations. Defines project timelines based on the identified GAPs identifies and interacts with the st...