Senior Regulatory Affairs Specialist

• Prepare and review regulatory dossiers in CTD format for the US market (BLA).
• Manage regulatory submissions and communications for sterile products, including Biotech and API manufacturing.
• Oversee international product registrations, including non-CTD formats and GMP Clearances/PMF for Asia and Africa markets.
• Ensure compliance with global regulatory requirements for sterile pharmaceutical products.
• Collaborate with Quality Assurance teams, focusing on sterility assurance.
• Support regulatory strategy development for new and existing products.
• Liaise with cross‑functional teams to gather and validate documentation for regulatory submissions.
• Monitor and interpret changes in regulatory guidelines impacting sterile and biotech products.

• Experience in regulatory affairs with a focus on CMC for sterile pharmaceutical products.
• Experience in Quality Assurance, specifically in sterility assurance.
• Experience with Biotech products and API manufacturing is a plus.
• Experience in preparing and submitting CTD dossiers for the US market (BLA), minimum 10 years.
• Experience in international registrations (non-CTD) and GMP Clearances/PMF for Asia and Africa markets.
• Academic background: scientific degree (e.g., Pharmacy, Chemistry, Biology) preferred.
• Fluent in English and Italian.
• Strong analytical and communication skills.

• An international community, bringing together 110+ different nationalities.
• An environment where trust has a central place; 70% of our key leaders started their careers at the first level of responsibilities.
• A robust training system with our internal Academy and 250+ available modules.
• A vibrant workplace that frequently gathers for internal events (afterworks, team building, etc.).

Amaris Consulting is proud to be an equal‑opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. We welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.