Regulatory Affairs Manager

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

We are looking for aRegulatory Affairs Managerto join ourRegulatory 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 overseeingregulatory documentationfor Marketing Authorization Applications (MAA), including CTD Modules.
Ensuringaccuracy, completeness, and consistencyof regulatory submissions, in line with international guidelines and client requirements.
Planning, coordinating, and managingregulatory procedures(e.g. MAA, variations, line extensions, renewals) across EU and non?EU markets.
Providingregulatory support to clinical development and CMC projects, ensuring alignment with overall development plans.
Coordinating multidisciplinary teams and managing timelinesto ensure high-quality deliverables and compliance with deadlines.
Supporting clients in regulatory decision-making through arisk?agevolazioni approach.
WHAT ARE THE REQUIREMENTS?
Master's degree inPharmaceutical Chemistry and Technology, Pharmacy,



or related scientific fields.
At least5 of experiencein Regulatory Affairs within the pharmaceutical sector.
Strongknowledge of EU and international regulatory frameworks(EMA, FDA, ICH), with experience managing multi?country projects.
Excellent command ofEnglish, both written and spoken.
Strongproject managementskills, excellentcommunicationabilities, and ateam oriented mindset, with the capacity to coordinate complex projects, facilitate stakeholder dialogue, and collaborate effectively within multidisciplinary teams.
CCNLCommercial 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 programfor 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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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7blbyi