For a multinational company in the pharmaceutical field we are looking for a Regulatory Affairs Manager.
Sebbene l'esperienza professionale e le qualifiche siano fondamentali per questo ruolo, si assicuri di verificare di possedere le soft skill preferenziali, se richieste, prima di candidarsi.
The Regulatory Affairs Manager is responsible for managing regulatory activities for an assigned product portfolio. The goal is to secure and maintain marketing authorizations, ensure compliance with local and EU regulations, review promotional materials, and support internal functions in business development.
Work site: Milano and 2 smart working days
Contract: 12 months fixed term
Range RAL: 40000€ - 50000€
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.
Requirements
● Degree in Pharmacy, Chemistry, Biology, or a related field.
● Minimum of 2 years of operational experience in Regulatory Affairs.
● In-depth knowledge of National and European regulations and experience in their daily application.
● Native-level Italian (or equivalent) and fluent in English.
Skills & Abilities
● Proven ability to manage projects and prioritize tasks.
● Excellent communication skills and a strong attitude for teamwork within matrix organizations. xjrgpwk
● Detail-oriented with a strong sense of responsibility and the ability to adapt to new systems and procedures.
● Ability to use AI tools to support daily activities