Aurora Gonzalez Email & Phone Number

Venezuela

Bogotá D.C. Area, Colombia

-Define regulatory strategies for initial registrations, licefcycle management and implementation of new manufacturing sites together with local and global regulatory colleagues in alignment with the specific LATAM market regulations. -Review dossier content for consistency, accuracy and completeness to ensure that BoH requirements are met and identify.

Bogotá, Capital District, Colombia

-Lead discussions supporting the creation and delivery of regional and national regulatory filing components for the product lifecycle and new registration filing plans in LATAM in partnership with global regulatory colleagues. -Contribute to the completion of complex projects as a Project Manager in order to meet agreed objectives and participate in.

Colombia

-Management of Innovative products (Vaccines, Biological, Marketing Auhtorization Aplications), supporting regulatory strategy and submission local process by developing strong partnerships with in-country team and regional teams.-Lead the escalation, anticipation and mitigation of risks and participation in regulatory intelligence process.-Manage and.

Caracas Area, Venezuela

-Management and sponsorship of Innovative portfolio in Venezuela (Vaccines, Biological & New Drug Applications) and lifecycle maintenaince within an environment of uncertainty and reduced costs.-Assistance to audiences with the board of health as well as multidisciplinary meetings in the Venezuelan Medicine chamber.

Miranda Area, Venezuela

Regulatory Strategist of the SouthAmerica Cluster in charge of implementing and managing regulatory vendors for Bolivia, Paraguay and Uruguay, ensuring compliance with the regulatory submission plan in those countries as well as the oversigth plan (surveillance) established for quality and confidentiality standards for the vendors

Miranda Area, Venezuela

-Evaluation and preparation of the dossiers received from the parent company in order to guarantee that the technical, clinical and legal information of the pharmaceutical product complies with all local regulations in order to be registered in the country as well as maintaining the sanitary registry of each updated product. according to current.

Venezuela

Evaluation and preparation of the dossiers received from the parent company in order to guarantee that the technical, clinical and legal information of the pharmaceutical product complies with all local regulations in order to be registered in the country as well as maintaining the sanitary registry of each updated product. according to current.

Venezuela

Maintain communication between the company and the health authorities of the country, in everything related to sanitary registration of generic drugs, their renewal and changes after registration; in addition to ensuring that they comply with the standards established by the sanitary regulatory bodies of the country for their registration and.

Venezuela

Development and validation of analytical methods of drugs by HPLC and volumetry.Schedule Natural Stability Studies for commercialized products.Prepare the weekly test plan for each analyst as well as his annual evaluation.Preparation of documents such as: Validation protocols, analysis technique, standard operating procedure.Management of results outside.

Miranda Area, Venezuela

Development of analytical inhouse methods and pharmacopoeial methods adapted to local development products

Diploma, Regulatory Affairs

Diploma in Health Regulation of Medicines

Pharmacist, Pharmacy

Activities and Societies: Internship in Laboratory of Food Science. Musical Band (Guitar player)