Regulatory Affairs Specialist (Protected Categories – Law 68/99)

Regulatory Affairs Specialist (Protected Categories – Law 68/99) RPN provides pharmaceutical and life science companies with the strategic, in-market, and executional expertise needed to deliver successful Regulatory Affairs and Market Access outcomes throughout the entire product life cycle and across international markets. We are seeking a Regulatory Affairs Specialist to ensure pharmaceutical products comply with all relevant regulations and guidelines. The role involves managing regulatory submissions, liaising with health authorities, and supporting the product lifecycle from development to post-marketing. Tasks and Responsibilities: Preparing strategy and technical documentation , submitting through national and EU portals, and following up until approval of MRP, DCP, CP, and National Procedures for new marketing authorizations, variations, transfers, and renewals, in line with EU and national regulations. Supporting electronic submissions ( eCTD ) and preparing checklists and e-submission-ready documents for regulatory activities. Supporting post-approval requirements at the local level, including database updates, PI updates, artwork revisions, and communication with partners on behalf of MAHs. Providing pre- and post-marketing regulatory consultancy to ensure compliance with Italian regulations. Reviewing daily communications and regulations issued by Italian Authorities and EMA. Managing regulatory procedures in coordination with the client’s team and communicating with Regulatory Authorities, either jointly or on behalf of the client. Minimum 1 year of experience in similar roles. Master’s degree in Pharmacy, Chemistry, Pharmaceutical Technology, or related fields. Excellent proficiency in English (written and spoken). Soft Skills: Effective communication and teamwork . Strong attention to detail and organizational skills . Good time management and problem-solving . Work location: NB: The position is open to individuals belonging to protected categories (L.68/99). Our selection process respects Legislative Decree 198/2006 and is inclusive of candidates regardless of gender, sexual orientation, age, ethnicity, or religious beliefs. We promote diversity and inclusiveness. Seniority level Associate Employment type Full-time Job function Other Industries Pharmaceutical Manufacturing and Business Consulting and Services J-18808-Ljbffr

Location: provincia-di-pisa, IT

Posted Date: 6/18/2025