Key Responsibilities
● Ensure regulatory approval for new products, formulations, or indications and maintain existing Marketing Authorizations (MA), including variations via National, MRP, and Centralized procedures.
● Manage the end-to-end process of translation and implementation of labelling materials for assigned products.
● Coordinate activities related to educational materials from Risk Management Plans (RMP) and Direct Healthcare Professional Communications (DHPC) as required by Regulatory Authorities, overseeing local implementation.
● Provide regulatory expertise within cross-functional teams (including Market Access, Medical, Marketing, Sales, Pharmacovigilance, Quality, Finance, etc.).
● Evaluate and review promotional and congress materials to ensure compliance with local requirements and Corporate Procedures.
● Support inspections and audits by providing appropriate regulatory input.
● Contribute to the development and optimization of regulatory processes and Standard Operating Procedures (SOPs).
● Guarantee full compliance in alignment with local regulations and Corporate Procedures.
