AbbVie Regulatory Affairs Analyst in Buenos Aires, Argentina
Regulatory Affairs Analyst
Argentina, Ciudad Autónoma de Buenos Aires, Buenos Aires
The mission of the Regulatory Affairs Analyst is to cooperate with the Direction in obtaining the Marketing Authorizations Certificates from the Regulatory Body for the new products AbbVie Argentina decides to launch to market as well as updates and/or modifications to be introduced in products already approved by the Health Authorities.
• Collaborate with product registrations, variations and renewals, according to the local regulatory framework.
• Provide support to the submission strategy.
• Interact with the Health Authorities on behalf of Abbvie’s interests
• Take over to keep the files updated (electronic and paper file).
• Be responsible of keeping updated the product´s certificates in each opportunity that a change is approved by the HA.
• Development of new processes internal procedures of Abbvie.
• Review of promotional materials.
• Maintain adequate training to comply with the broad spectrum of regulatory activities required in the country
• Be the liason with the QA area in order to assist submissions of quality documents to ANMAT / INAME
• Provide regulatory guidance and documentations to import/export activities
• Provide assistance to Customer Service.
• Participate in maintaining the budget of the area (utilization of SAP as requestor).
• Implementation of Area Programs in the Affiliate
• Pharmacist or advanced student
• Minimum 5 years’ experience in Regulatory Affairs
• Knowledge of applicable regulations
• Negotiation skills
• English: advanced level
• Trained in applicable local and international policies and procedures
• Good communications skills