Job Description

GENERAL OBJECTIVE:
Guarantee high quality service to the client portfolio, ensuring efficient compliance with the processes under their responsibility or those assigned by Management.

SPECIFIC OBJECTIVES:
Ensure the company's regulatory compliance with local and international laws and regulations, keeping applicable legislation updated and representing the interests of the organization before government and union entities.
Participate in the planning, definition, implementation and monitoring of appropriate regulatory strategies and processes to guarantee the commercialization of products under their responsibility, including the health registration of new products, renewals, modifications and labeling, among others, in accordance with the health regulations in force in the countries they support and the company's policies in line with corporate needs and/or business departments.
Provide accurate and timely information about the products that are under your responsibility.
Provide support to the company in regulatory matters related to the products under their responsibility.

FUNCTIONS:
Define strategies for renewals, post-registration changes, new registrations and new indications in the region, in accordance with assigned responsibilities.
Supervise and support the preparation of files for regulatory procedures in the different countries of the products under their responsibility.
Coordinate and ensure the timely submission of regulatory procedures for the products under your responsibility.
Provide information on the regulatory strategy, times and requirements in different countries for internal departments that request it. Point of contact for the Commercial, Marketing, Logistics, Business Development, Legal, Corporate Affairs departments and any other department within the company that requires it.
Coordinate all regulatory activities with suppliers, both in the collection of documentation and requirements, as well as coordinate with the registrars in the countries for the submission, monitoring and approval of the different regulatory procedures. Interaction with the Ministry of Public Health and Social Assistance MSPAS is included.
Monitoring of shipments to the Ministry of Public Health and Social Assistance MSPAS in accordance with assigned responsibilities.
Ensure that all documents related to regulatory processes are properly filed in official databases, to ensure that the information presented and approved is available.
Ensure the constant updating of databases, local monitoring tools and other associated systems.
Provide support to other departments to ensure business continuity, including support in public bidding participation processes.
Provide the necessary support for audit processes.
Review and approve promotional materials for the products under your responsibility, ensuring compliance with current health regulations, in order to prevent sanctions, confiscations or withdrawal of materials for non-compliance.
Prepare standard operating procedures.
Prepare the reports and time reports required by the Regulatory Affairs Management, related to the products under their responsibility, within the established deadlines.
Complete billing reports required weekly by Regulatory Affairs Management. Likewise, if required, support with the review of the monthly billing carried out by the Regulatory Affairs Assistant.
Keep regulations up to date.
Supervise and support the Administrative and Regulatory Affairs Assistant.
Manage pharmacovigilance and technovigilance regulations.
Comply with the guidelines of the Integrated Management System: Quality, Environment and Occupational Health and Hygiene established in the Company, applicable to your job, abiding by the policies, plans and procedures that ensure adequate implementation and continuous improvement.

REQUIREMENTS:
Graduate in Pharmaceutical Chemistry
2+ years of experience in pharmacovigilance positions.
Intermediate English (desirable).
Analytical thinking and ability to interpret complex policies and regulations.
Excellent written and oral communication skills.
Ability to negotiate and represent institutional interests before external entities.
Organization and attention to detail for document management and compliance with deadlines.
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