Regulatory Affairs Specialist

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 SPECIALIST to join our 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.

Key Responsibilities

• Prepararing the regulatory documentations for marketing authorization application (CTD Modules).
• Ensuring consistency, completeness, accuracy and adherence to regulations and applicable guidelines and to the client’s need for all regulatory submissions.
• Providing assistance during the procedures for the preparation of response documents.
• Giving assistance during the procedure for preparation of the response document.
• Planning and managing regulatory procedures in the EU and outside the EU (e.g. new marketing authorization applications, variations, renewals, etc.) in coordination with the Client’s team and the contact with Regulatory Authorities together with or on behalf of the client.
• Giving support to the Client in the critical evaluation of the appropriate regulatory strategy.

Essential requirements

• Master's degree in Pharmaceutical Chemistry and Technology , Pharmacy or similar.
• At least 3-5 years of experience .
• Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
• Strong project management approach: a structured, proactive approach to supporting project activities, with the ability to coordinate tasks, manage priorities, and communicate clearly with stakeholders throughout different phases of the work.

Soft Skills

• Strong communication and teamwork abilities
• Attention to detail and solid organizational skills
• Effective time management and problem‑solving
• Adaptability and openness to continuous learning

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.