Arithmos is proud to announce the appointment of Giulia Bruno as the new Head of Regulatory Affairs. With nearly 36 years of expertise in the pharmaceutical industry, Giulia brings an exceptional depth of knowledge spanning the entire drug development process, from preclinical research to registration, with a primary focus on EU and US regulatory pathways.
About Giulia Bruno
Giulia has built her career in R&D, starting in the PK & Metabolism Department before spending more than 25 years in Regulatory Affairs. She has led numerous development and regulatory projects, successfully guiding companies through complex submissions, including centralised EU registrations, CTAs, INDs, ODDs, PIPs, MAAs, and NDAs.
Her leadership achievements include two major EU centralised procedures — one resulting in a $900 million product acquisition, and another involving a life-saving antimicrobial product in collaboration with WHO and MMV. In addition, she gave significant contribution to the latest company/products acquisition concluded by the previous company.
She has extensive experience in negotiations with regulatory authorities such as EMA, FDA, PMDA, and non-ICH agencies.
Her role at Arithmos
As Head of Regulatory Affairs, Giulia leads Arithmos’ regulatory strategy and service development. She provides expert guidance to clients across the full drug development lifecycle — from early-phase planning to global submissions — ensuring compliance, speed, and innovation. She will also support post-approval strategies, helping clients maintain market access efficiently.
Skills and Expertise
Giulia brings a proven track record in solving complex regulatory challenges, leveraging her deep knowledge of global regulations and accelerated approval pathways. She has hands-on experience in a wide range of therapeutic areas including gastrointestinal, cardiovascular, inflammation, metabolic disorders, antimicrobial, oncology, and onco-hematology.
Strategic Impact for Arithmos Clients
Giulia’s appointment marks a significant step in Arithmos’ commitment to delivering forward-looking, client-focused regulatory solutions. Her vision will enhance our ability to navigate complex global regulatory landscapes, achieve faster approvals, and mitigate compliance risks.
Clients will benefit from senior-level insights, improved operational efficiency, and assurance that their programs meet the latest global regulatory standards.
Why This Matters Now
The regulatory environment is undergoing rapid transformation. Regulatory authorities such as EMA, FDA, and PMDA are introducing new frameworks for AI/ML-based products, digital therapeutics, and advanced therapies, while post-Brexit divergence and evolving regional requirements add further complexity. Guidance is shifting more frequently, approval pathways are becoming more varied, and competition for accelerated routes like PRIME, Breakthrough Therapy, and Fast Track designation is intensifying.
Companies that fail to anticipate these changes risk costly delays, incomplete submissions, and missed market opportunities. Arithmos, under Giulia’s leadership, is uniquely positioned to help clients adapt quickly and strategically — from shaping early regulatory strategy to executing flawless submissions in multiple jurisdictions. Giulia’s proactive approach to authority engagement, her experience in securing accelerated approvals, and her ability to align scientific innovation with regulatory expectations give our clients a decisive competitive advantage.
Partnering for Regulatory Success
Giulia’s arrival at Arithmos is more than an appointment — it’s a catalyst for our clients’ success in a complex and fast-moving regulatory world. Her insights and leadership enable us to deliver tailored, end-to-end regulatory strategies that shorten time-to-market, protect compliance, and unlock new opportunities for growth.
Whether you are developing a breakthrough therapy, expanding into new markets, or optimising your post-approval portfolio, Arithmos now offers a regulatory partnership that blends deep industry expertise with hands-on operational execution. We don’t just interpret regulations — we turn them into strategic advantages.
Connect with us today to discover how Giulia and our Regulatory Affairs team can help you move forward with confidence, clarity, and speed.
