International Regulatory Affairs Manager

We provide pharmaceutical and life science companies with the strategic, in-market, and executional expertise needed to deliver successful Regulatory Affairs and Market Access outcomes throughout the entire product life cycle and across international markets.

We are looking for a Regulatory Affairs professional to join our growing International Team.

You will play a key part in managing regulatory requirements to support product development, registration, and lifecycle management across multiple markets . Your knowledge will ensure compliance with local and international regulations, helping to successfully launch and maintain innovative products globally.

What will you be responsible for?

• Preparing regulatory documentation for development programs (IMPDs/INDs, IBs, CTAs, Scientific Advice, Orphan Drug Designation).
• Supporting marketing authorization applications (CTD Modules) and managing regulatory variations (Module 3 updates).
• Conducting risk assessments (elemental impurities, environmental risks) and ensuring compliance with applicable guidelines.
• Coordinating and preparing responses to regulatory authorities during procedures and interactions.
• Identifying risks in submissions and proposing proactive mitigation strategies.
• Collaborating with internal teams and regulatory authorities to ensure timely and successful submissions.
• Planning and managing EU and non-EU regulatory procedures (MAAs, variations, renewals).
• Supporting regulatory strategy development and providing guidance to clients.
• Contributing to project management activities and mentoring junior regulatory staff.

Do you meet these essential requirements?

• Master’s degree in Pharmaceutical Chemistry and Technology , Pharmacy or similar.
• At least 8 years of experience .
• Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.

Do you bring the following interpersonal skills?

• Strong attention to detail and a structured working approach.
• Proactive mindset with solid problem-solving abilities.
• Excellent communication skills.
• Flexibility and adaptability in a dynamic environment.

Work place:

Pisa - hybrid position.

If you meet the requirements, don’t miss out on this opportunity - apply now!

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.