Job DescriptionJoin our team as a Regulatory Affairs Consultant in our international and dynamic environment. You will act as a technical and functional expert in the sterile pharmaceutical field, acting as an ambassador of Amaris Consulting to our clients. Responsibilities 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. Qualifications 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 English and Italian. Strong analytical and communication skills. Benefits An international community with 110+ different nationalities. Trust‐based environment where 70% of key leaders started at entry level. Robust training system with internal Academy and 250+ modules. Vibrant workplace with regular internal events (afterworks, team building, etc.). Diversity and InclusionAmaris Consulting is proud to be an equa