In Buenos Aires (Argentina), we are looking for a Regulatory Affairs Ssr. Analyst :
Under leadership of the local Regulatory Affairs & Technical Director, as a Regulatory Affairs Ssr. Analyst you should contribute to the activities for the registration of products in the appropriate government agencies, the health and environment permits required, as well as the technical support of products within its business area, in accordance with the policies and guidelines of the Organization.
Your Main Responsabilities
Give support in submissions of new products, variations and renewals before the National Sanitary Authorities (ANMAT, INAME, Medical Technology) related to imported and local products (including on-line submission).
Assist the Technical Director with the Health Authority inspections and audits from Headquarter.
CTD of local products.
Give support in submissions of new products, variations and renewals on the National Sanitary Authorities of Uruguay, regarding imported and local products.
Support in the Regulatory Information Management System for Argentina and Uruguay
Review art works of packaging and promotional materials prior to the signature by the Technical Director.
Give support in submission about on our Manufacturing Site
Assist the local Pharmacovigilance Officer in pharmacovigilance activities in Argentina and Uruguay.
Required Experience & Competences
Preferably University Degree in Pharmacy, Biotechnology, Biology, Biochemistry or related fields.
Minimum of 2 years’ experience in Regulatory Affairs within pharmaceutical industry.
Action Oriented, Customer Focus, Organizing, Prioritizing, Strong communication skills, Strong analytical / problem solving skills will be required
In case you meet all the requirements, don’t hesitate to apply!