THE COMPANY

Pharmaceutical Multinational Company

Central and Latin America

Regulatory Affairs Lead

THE ROLE

• Management of scientific documentation relevant to the Central and Latin America registrations of the pharmaceutical products;
• Works together with the regional team in order to finalize the best strategy to register and maintain the product portfolio;
• Planning/organizing activities for preparing new registration plans and for maintaining the existing registrations through variation procedures and renewals;
• Oversees on existing licences 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;
• 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.
• Regulatory Intelligence as far as it concerns new regulations and guidelines to be shared with Corporate teams;
• Co-ordination of the activities related to the completion and implementation of internal Standard Operating Procedures
• Maintains staff by recruiting, selecting, orienting, and training employees; maintaining a safe, secure, and legal work environment; developing personal growth opportunities.
• Contributes to team effort by accomplishing related results as needed.
• Accomplishes financial objectives by supporting the Rest of the world Manager in forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.

JOB REQUIREMENTS

• Bachelor Degree in scientific environment, including, but not limited to, Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Chemistry is mandatory;
• At least 5 Years of experience;
• Fluent in English;
• The candidates should be dynamic, proactive and willing-to-do person
• The candidate should have excellent interpersonal, organizational and communication skills, capability in working in a team, good problem solving and leadership attitude 

LOCATION: Toscana