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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7crx1s

We are looking for a REGULATORY AFFAIRS professional who will ensure that pharmaceutical products comply with all applicable regulations and guidelines, managing regulatory submissions, interactions with health authorities, and supporting the product lifecycle from development to post-marketing.
**Tasks and Responsibilities**:
Preparing the 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, marketing authorization transfers, and renewals in accordance with relevant EU regulations and national requirements.
Supporting electronic submissions (eCTD), and preparing checklists and e-submission-ready documents for various regulatory activities.
Supporting the fulfillment of post-approval requirements at the local level (database updates, PI updates, artwork revisions,



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 the Italian Authorities and EMA.
Managing regulatory procedures in coordination with the client’s team and handling communication with Regulatory Authorities, either together with or on behalf of the client.
**Essential requirements**:
At least 1 year of experience in similar roles.
Master’s degree in Pharmacy, Chemistry and Pharmaceutical Technology or related degree program.
Excellent knowledge of the English language (written and spoken).
**Work location**:
Pisa (hybrid position).

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7crx1s