Regulatory Affairs Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ixnye

We are looking for a
Regulatory Affairs Manager
to join our
Regulatory Affairs Team.
WHAT WILL YOU DEAL WITH?
Strategic Regulatory activities:
Supporting the definition of global and regional regulatory strategies, identifying optimal registration pathways based on product characteristics, development stage and target markets.
Providing strategic guidance to clients on regulatory requirements and potential risks, ensuring compliance with EU and international frameworks.
Regulatory Affairs activities:
Preparing, reviewing, and overseeing
regulatory documentation
for Marketing Authorization Applications (MAA), including CTD Modules.
Ensuring
accuracy, completeness, and consistency
of regulatory submissions, in line with international guidelines and client requirements.
Planning, coordinating, and managing
regulatory procedures
(e.g. MAA, variations, line extensions, renewals) across EU and non-EU markets.
Providing
regulatory support to clinical development and CMC projects
, ensuring alignment with overall development plans.
Coordinating multidisciplinary teams and managing timelines




to ensure high-quality deliverables and compliance with deadlines.
Supporting clients in regulatory decision-making through a
risk-agevolazioni approach.
WHAT ARE THE REQUIREMENTS?
Master's degree in
Pharmaceutical Chemistry and Technology, Pharmacy, or related scientific fields.
At least
5 of experience
in Regulatory Affairs within the pharmaceutical sector.
Strong
knowledge of EU and international regulatory frameworks
(EMA, FDA, ICH), with experience managing multi-country projects.
Excellent command of
English
, both written and spoken.
Strong
project management
skills, excellent
communication
abilities, and a
team oriented mindset
, with the capacity to coordinate complex projects, facilitate stakeholder dialogue, and collaborate effectively within multidisciplinary teams.
CCNL
Commercial Sector
Type of contract:
permanent
Salary range (RAL):
€40,000 - €45,000.
The actual compensation of

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ixnye