Regulatory Affairs Central and Latin America Coordinator

Are you a highly motivated and detail-oriented regulatory professional looking to make a significant impact on a global scale? Do you thrive in a fast-paced environment where your expertise directly contributes to bringing life-changing products to market?

Our Global Regulatory Affairs Department is seeking a dedicated individual to join our mission. In this critical role, you will be at the forefront of ensuring our products meet all international regulatory requirements, driving successful submissions, and maintaining compliance across diverse markets.

You will be responsible for strategically planning and organizing all activities related to the preparation of new product registration plans and regulatory procedures. This includes managing the maintenance of existing Menarini Primary and Specialty Care product registrations within your assigned geographical area.

This role requires close collaboration with technical functions and local/regional regulatory teams to ensure timely and compliant global market access.

In according to the Specific Geographical Area of reference assigned, you will:

• provide support to the RA associate in planning/organizing activities for preparing new registration plans and maintenance of the existing registration through variation procedures and renewals;
• work together with the technical functions and the regional team in order to finalize the best strategy to register and maintain the Menarini Group product portfolio;
• work in cooperation with technical functions and local regulatory team for planning activities for preparing new registration plans and for maintaining the existing registrations through variation procedures and renewals;
• oversee existing licenses towards the finalization of the master data package to be transferred to the regional office in order to proceed with the customization and submission of the proper application. Work in cooperation with internal functions and local team for planning the activities related to new registrations and lifecycle management;
• provide compliance check on the content of existing licenses and proper application of the existing process and Company procedures;
• liaison with the other Company departments (R&D, Marketing, Manufacturing, PV….) in order to solve all the specific requests coming from the Regulatory Authorities.
• provide regulatory Intelligence as far as it concerns new regulations and guidelines to be shared with Corporate teams;
• Coordinate the activities related to the completion and implementation of internal Standard Operating Procedures
• Maintain staff by recruiting, selecting, orienting, and training employees; maintaining a safe, secure, and legal work environment; developing personal growth opportunities.
• Contribute to team effort by accomplishing related results as needed.
• Accomplish financial objectives by supporting the Rest of the world Global Lead in forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.

Master degree or higher in scientific fields is mandatory.

• At least 5 years of experience in coordinating International Regulatory Affairs team or in an equivalent role is preferred, incluing experience with the Region in scope (Central and South America)
• Proven track records of successful regulatory applications in the Region
• Fluent spoken and written English; knowldege of Spanish would be a plus
• Dynamic, proactive and willing-to-do person
• Excellent interpersonal, organizational and communications skills; capability of working in a team, good problem solving and leadership attitude
• Experience in people coordination is preferred.