Senior Digital Regulatory Consultant Life Sciences

Company

A leading international organization specializing in consulting and digital solutions for the Life Sciences sector, with headquarters in Italy. Established in 2010, the company supports pharmaceutical and biotech organizations across regulatory affairs, pharmacovigilance, clinical trials, medical affairs, and quality assurance. It delivers innovative digital tools and high value-added services, with a strong focus on regulatory compliance and operational efficiency.

As a Senior Digital Regulatory Consultant, you will act as a key point of contact for international clients, with responsibility for requirements analysis, technology solution design, implementation coordination, and change governance.

You will work closely with internal IT teams, developers, product specialists, and regulatory functions, ensuring alignment between client needs, regulatory compliance, and technical deliverables.

• Lead the design and implementation of digital regulatory systems (RIM, eCTD, IDMP, PV systems, Quality Systems)
• Coordinate internal and external technical and functional teams, ensuring quality, timelines, and compliance with requirements
• Translate regulatory requirements into implementable technical specifications
• Analyze existing regulatory processes (submission management, labelling, safety, clinical) to identify inefficiencies, risks, and opportunities for digital transformation
• Advise clients on technology architecture, digital tools, system integrations, and evolutionary roadmaps
• Monitor KPIs, project progress, budgets, and the impact of implemented solutions
• Contribute to the definition of the digital portfolio and the development of new, high-tech services

• Have at least 7–10 years of experience in the Life Sciences sector, in technical or digital/IT transformation roles
• Have worked in regulatory affairs, pharmacovigilance, QA, or clinical environments, preferably within pharmaceutical, biotech, or CRO organizations
• Hold a degree in Computer Science, Engineering, Bioengineering, Chemistry, or Pharmacy, with strong digital expertise
• Have solid knowledge of RIM systems, eCTD, IDMP, digital platforms for regulatory and PV, API integrations, workflow automation, data governance, GxP, and EMA/FDA guidelines
• Have at least 5 years of consulting experience, including client management and delivery of complex projects

• Permanent employment contract
• Competitive salary and benefits package
• Flexible working arrangements (full remote or hybrid options)
• Collaboration with multidisciplinary teams on international projects
• Opportunities to contribute to business growth and the development of the digital offering

All vacancies are open to candidates of all genders (Law 903/77).

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