Regulatory Affairs Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/84ydc3

For a multinational company in the pharmaceutical field we are looking for a Regulatory Affairs Manager. 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 lavoro da remoto days Contract: 12 months fixed termRetribuzione annua: 40000€ - 50000€esperienza2 anni
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.




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
La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad ( ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
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 A

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/84ydc3