Regulatory Affairs Manager
Pubblicato il 05-08-2026 - Regulatory Pharma Net - Rpn in Milano
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 offered may vary based on several factors, including job-related qualifications such as knowledge, skills, education, experience, and location.
Birthday leave
Buddy program
for onboarding: from day one, you'll be supported by a dedicated contact to help you settle in and integrate with the team
The selection, respects Legislative Decree ******** and is open to candidates of any orientation or expression of gender, sexual orientation, age, ethnicity and religious belief.
This announcement is designed to respect diversity and inclusiveness.
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