- Responsible for leading regulatory submissions for registrations, post-registrations, renewals, GMP certification, and requirements for new, branded generic, biological, cosmetic, and health products, also in CTD model; - Team leader responsible for the development, definition, establishment, and supervision of regulatory strategies to maximize regulatory success towards achieving the company’s objectives, along the local, regional, and global teams; - Ensuring compliance with policies, rules, procedures, and legislation; - Department budget management; - Creation and implementation of a regulatory intelligence model; - Management and evaluation of promotional materials and internal processes; - Company representative in working groups and meetings with trade associations and health authorities; - Team development aimed at streamlining and improving regulatory activities; - Direction for the preparation and submission of product certifications (Inmetro); - Support in internal and external audits.

- Technical analysis of documentation for registration and variations (including Drug Master File);- Emphasis on registration and post-registration processes for drug products, cosmetics and health products;- Regulatory intelligence;- Annual Report (HMP);- Renewals of registration of drug products, cosmetics and health products;- Answers to queries from the regulatory bodies;- Leaflet, labeling, promotional material;- Opinion of Technical Analysis of the Company (PATE);- Certification of Good Manufacturing Practices for national and international manufacturers;- Meetings with trade associations to discuss legislation and standards;- Regulatory support to internal and external customers;- Internal training on promotional activities and requirements for medication registration;- Standard Operating Procedures.

- Experience with new, branded generic, generic, specific, clones, simplified notification, biological drugs and cosmetics;- Regulatory evaluation of registration, variations, registration renewal, and Annual Reports (HMP);- Execution of regulatory intelligence and project feasibility procedures, focused on defining product registration strategies;- GMPc renewals for international API manufacturers;- Answers to queries of regulatory bodies;- Elaboration of package leaflet text and labeling for regulatory submission;- Evaluation of promotional materials;- Implementation of workflow and internal procedure for product discontinuation and recall processes;- Participation in meetings with trade associations and health authority.

- Emphasis on analysis and processing of market complaints.

- Management of technical documentation;- Creation and review of SOP and CAPA;- Training in Good Manufacturing Practices;- Participation in audits.

- Interface with regulatory affairs areas in Brazil and Latin American countries, preparing documentation for registration, variations and technology transfer, in CTD format;- Control and management of quality technical documentation and standard operating procedures.