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 MANAGER to join our INTERNATIONAL TEAM.

In this role, you will lead complex regulatory activities to support the development, registration, and lifecycle management of pharmaceutical products across EU and non‑EU markets. Your experience will enable clients to build effective regulatory strategies and execute high‑quality submissions, ensuring compliance with global regulations.

Key Responsibilities:

• Preparing, reviewing, and overseeing regulatory documentation for Marketing Authorization Applications (CTD Modules).
• Ensuring accuracy, completeness, and consistency of regulatory submissions, in line with international guidelines and client requirements.
• Plan and manage regulatory procedures in the EU and beyond (e.g., MAA, variations, line extensions, renewals).
• Contribute to the definition of global regulatory strategies , supporting clients in selecting the optimal pathway based on product development stage.
• Support regulatory planning within clinical development and CMC projects.

Essential Requirements:

• Master’s degree in Pharmaceutical Chemistry and Technology, Pharmacy, or related scientific fields.
• 5–8 years 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 mindset , with the ability to coordinate multiple regulatory activities while ensuring quality and meeting deadlines.

Soft Skills:

• High level of autonomy and ownership .
• Strong analytical and advanced problem‑solving skills .
• Clear communication and client‑oriented attitude .
• Ability to make regulatory decisions based on a risk‑benefit perspective .

Contract details:

• Type : Permanent
• Location : Pisa or Milan
• Hybrid work

Benefits:

• €10 meal voucher per working day
• Competitive corporate welfare plan
• Birthday leave

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.