Regulatory Affairs Consultant

Amaris Consulting

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects since 2007 – this has been made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different business lines: Information Systems & Digital, Telecom, Life Sciences, and Engineering. We’re focused on building and nurturing a top talent community where all team members can achieve their full potential.

Position Overview

Join our team and start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast‑growing organization. As a consultant at Amaris Consulting, you will position yourself as a technical and functional expert in an industrial field, and above all, serve as an ambassador of our organization to clients. You will need strong interpersonal skills to build trust with clients, and a curiosity and eagerness to learn to support our diverse client base worldwide.

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 in English and Italian
• Strong analytical and communication skills
• Strong interpersonal skills and ability to listen, building trust with clients and fully understanding their challenges and issues
• Eagerness to learn and develop within a fast‑growing organization

Benefits

• International community, bringing together 110+ different nationalities
• Environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• Robust training system with our internal Academy and 250+ available modules
• Vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• Commitment to sustainability: You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.

Diversity and Inclusion

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. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

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