Claudia Percivalle

WORK HISTORY

EDUCATION

ABOUT CLAUDIA PERCIVALLE

I am a Global Regulatory Affairs Leader with a strong regulatory knowledge in regulatory strategy, regulatory CMC, labelling, pharmacovigilance and more than 10 years experience in drug development in general. Having a PhD in Chemistry allows me to leverage my solid background in organic and analytical chemistry to deliver technical solutions within the regulatory space and to interact at the best with cross-functional team across clinical, non-clinical and CMC functions. Experienced in managing commercial products and leading interactions with Quality, supply chain, commercial and marketing functions. I am a self-starter and self-motivated individual, passionate about applying my regulatory knowledge and technical skills to bring alternative therapies to the market fasters providing patients with alternatives to their current treatments and improve their quality of life. To achieve my goals, I am eager to keep learning and to build teams and processes that will allow to overcome obstacles and achieve a common goal. My core competencies are: Experienced in global regulatory strategy across different markets (US, EU, Canada, MENA, APAC) for hybrids / 5050(b)2 types / generics pharmaceutical products with particular emphasis on developing treatments for rare diseases in metabolic and neurology therapeutic areas. Experienced with solid dosage forms (tablets, capsules, soluble tablets) IR products, ODTs and injectables products. Proven track record in managing highly productive and over overachieving teams, able to lead through uncertainty such as during the COVID-19 pandemic in a fully remote working mode in high-pace and fast evolving environment such as small pharmaceutical companies/startups and in a big pharma matrix environment. Experienced in MAA submissions, dossier compilation and review, responses to questions for Health authorities, clinical trials applications, PIPs and Health Authorities advice. Demonstrated ability to create strong relationships with Regulatory Agencies and internal and external stakeholders. Strong technical background within regulatory (strategy, CMC, labelling, pharmacovigilance) and the chemistry space (organic chemistry, analytical chemistry, bioanalysis, pharmacokinetics) with a PhD in Organic Chemistry and experience in research in academic environment.@ClaudiaPercival