Regulatory Affairs Manager

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‑benefit 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 198/2006 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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