Current position and relevant professional experience:
Over the past 15+ years, I had the opportunity to gain deep knowledge in regulatory affairs primarily as well as several other aspects of the pharmaceutical industry, thus gaining a comprehensive understanding of the full end-to-end R&D Value Chain and built a strong network of regulatory connections globally.
In my current role at BASE life science - an Infosys company, I am heading up the Regulatory & Safety Advisory Team and its offering catalogue and I am an active member of the Business Consulting Leadership team, supporting business development initiatives and value creation across large, medium and small companies around the world. Additionally, given that I am currently located out of Italy thanks to the fully remote-nature of my employment contract, I am also covering local representative responsibilities on behalf of the CEO of the organization head-quartered in Copenhagen, Denmark.
Throughout my career, I had the privilege to be exposed to several aspects of the regulatory work (starting over 15 years ago upon joining the local Italian affiliate of Allergan in Rome, to the management of regional product life cycle for various registered OTC, Medical Devices and Cosmetic products when in the Regulatory UK, Ireland & Malta team at Pfizer Consumer Healthcare in Maidenhead to more global regulatory roles when in PGT Healthcare (former Joint Venture between P&G and Teva) in Harlow or at CSL in Melbourne, Australian where I was heading up the Global Regulatory Operations, Compliance & Business Excellence team and strategy.
A blend of international industry as well as consulting experience, including 4-years acting as Director for a privately held LTD company called EUREKA! Consulting Solutions based in UK, offering specialized Regulatory Advisory to companies in the Life Science industry in Digital Transformation, Technology and AI services, which am hopeful to bring to the TOPRA Board of Directors.
Current or previous involvement in TOPRA activities:
I joined TOPRA as active member in 2012 and since 2018, I have been part of the Regulatory Operations Special Interests (RegOps SPIN) Steering Group, actively contributing to the development of the RegOps SPIN Community.
As volunteer, I have actively participated to regular SPIN SteerCo meetings and other TOPRA Events (e.g. speaking about “the role of RegOps” at TOPRA Career Fair at the University of Hertfordshire in May 2019 and facilitating the “EU ISO IDMP/SPOR session” at TOPRA Annual Symposium in 2020), to the authoring of several articles for the TOPRA Regulatory Rapporteur (see “Regulatory Operations in the era of AI” published in April 2019, “Mergers and Acquisitions in Pharma - A Growing Trend” published in April 2020, “How Data Remediation and Stewardship is becoming a standard responsibility for Regulatory Operations professionals” published in Sept 2022 and “Digital People Strategy for AI” published in Feb 2024) as well as the organisation of Webinars and Podcasts (e.g., “The Power of Regulatory Data Mining Webinar” held in October 2019, “eRA SPIN Round Table” held at the TOPRA Offices in London in December 2019, “IDMP/DADI Preparation Webinar” held in October 2022 or the Podcast “RegRapPod: In Conversation with TOPRA’s RegOps SPIN” published in Feb 2024).
In March 2024, I was rewarded the TOPRA Fellowship status (FTOPRA).
Personal statement:
Valeria is a FTOPRA who brings to the Board of Directors of TOPRA, an organization for which she has active membership since 2012, a fresh blend of international industry as well as consulting experience. Having worked for more than 15 years in the Life Science industry across local, regional and global regulatory roles, she has developed a comprehensive understanding of the full end-to-end R&D Value Chain and built a strong network of regulatory connections globally. In her free time, she enjoys spending quality time with family as well as being involved in volunteering and other personal development opportunities.
Nomination information
Proposer: Eva Kopecna; Seconders: Steve Hayes, Michael Banks