Highlights:Strategic leader in Regulatory Affairs holding a Regulatory Affairs Certification (RAC- Global) from RAPS (Regulatory Affairs Professional Society-USA) & diploma in Project Management (PMP) and Business Administration with over 18y of strong experience navigating the complex landscapes in Latin American region ( Lan cluster & central America) by providing strategic and operational direction /relationship / oversight for the planning, management, and execution of regulatory activities for biopharmaceuticals.

Skills:

Certification:Regulatory Affairs Professional Society (RAC) Global Scope

Asoc. REGULATORY AFFAIRS MANAGER Latin American Cluster North (LAN) _LoC Peru / Ecuador 07/2022 - current
Johnson & Johnson, Lima, Lima Peru
Industry: Pharmaceutical
-Responsible for managing & oversight the regulatory commitments for the countries under scope
-Responsible for managing & oversight the regulatory commitments for the countries under scope (pharmaceuticals products) Oncology | Infection | Neurosciences -Built relationship with Pharmaceutical chambers / Internal & Stakeholders with the aim to move forward companies’ initiatives. -Provide Regulatory intelligence input to business. -Market regulatory intelligence -New projects timelines -Product lifecycle management -Ensuring business compliance and implementation of and adherence to regulatory standards. -Ensure an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, and that these regulatory positions supporting the business are, communicated and executed on time to the required quality standards. -Responsible for ensuring that regional regulatory strategies are executed in compliance with current, applicable regulations and corporate standards. -Ensuring regulatory plans are monitored, progress is communicated to Business/ Senior -Management and any risks (from emerging technical data, changing internal objectives or external impacts) are mitigated -Measure, monitor, manage and present regulatory performance metrics of the countries under scope--
SENIOR REGULATORY AFFAIRS MANAGER 01/2016 - 07/2022
Teva Pharmaceuticals, Lima, Lima Peru
Industry: Pharmaceutical
-Responsible for managing the regulatory commitments in Perú /Ecuador/CL/ Uruguay, / Venezuela / Caribbean countries
-Responsible for managing the regulatory commitments in Perú /Ecuador/CL/ Uruguay, / Venezuela / Caribbean countries -Responsible for ensuring that regional regulatory strategies are executed in compliance with current, applicable regulations and corporate standards. Provide Regulatory intelligence input to business New projects timelines / Product lifecycle management / Market regulatory intelligence -Responsible for managing the regional regulatory data for new registration/ renewals / variations /CDS and get them duly updated into the regulatory system in compliance with regional KPIs. -Measure, monitor, manage and present regulatory performance metrics of the region. -Keep update the business about regulatory requirements as well as of international guidelines such ICH, EU, FDA, Latin American countries regulations. -Close interaction with regional teams (CMC, R&D, Supply, Medical) to achieve filings / submission / approvals / launches according to corporate goals. Regulatory point of contact in the top regional management team.--
REGULATORY AFFAIRS ANALYST MSD (PE) 11/2010 - 03/2014
MERCK, Lima, Lima Peru
Industry: Pharmaceutical
Follow up the application of each process: New registration / Renewals / CMC /label changes in Latam & Central Caribbean countries
? Attend meetings with Peruvian Health to resolve regulatory issues related to MSD products. -Follow up the application of each process: Registration / Re-registration / CMC /label changes. -Provide input to local and corporative stakeholders on product lifecycle planning and regulatory status. which may affect current portfolio. -Manage and prepare the final product submission dossier. -Follow up the on-going applications by negotiating and communicating effectively with National Regulatory Authorities to obtain timely product approvals--
REGULATORY COMPLIANCE AFFAIRS COORDINATOR 01/2006 - 11/2010
PFIZER, Lima, Lima Peru
Industry: Pharmaceutical
-Coordination with Head Quarters to ensure compliance of the regulatory information in accordance with local regulations and corporate policies. (Regulatory Conformance).
-Transfer of registered data and updating of electronic regulatory information system -Support to Quality area, through the Regulatory Impact Assessment Change Requests, Deviation and implementation of CAPA, provide regulatory evaluation for investigations associated to manufacturing deviations and troubleshooting activities -Assist in the development and support of the company audit program (compliance & regulatory) to ensure timely and effective corrective/preventative actions are developed, implemented, and verified. -Perform risk-benefit analysis for regulatory compliance and to prepare monthly reports to the Regional Compliance Office. -Provide regulatory compliance information within the company including change controls, packaging specifications, product specifications, product literature, Annual Product Review Requirements--

San Marcos University 01/2001 - 12/2005
Lima, Lima, Peru
Degree: Bachelor's Degree
Major:Pharmacy
Pharmacy

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