Senior Digital Regulatory Consultant Life Sciences

20 ore fa


Lazio, Italia Cpl & Taylor By Synergos Srl A tempo pieno

CPL & TAYLOR by Synergos is recruiting: SENIOR DIGITAL REGULATORY CONSULTANTLIFE SCIENCES(Ref. ANN******)Location: full remoteContract: Permanent, full-timeCompensation: To be defined based on experienceThe CompanyA leading international organization specializing in consulting and digital solutions for the Life Sciences sector, with headquarters in Italy.Established in ****, 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.The RoleAs 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.Key ResponsibilitiesLead 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 requirementsTranslate regulatory requirements into implementable technical specificationsAnalyze existing regulatory processes (submission management, labelling, safety, clinical) to identify inefficiencies, risks, and opportunities for digital transformationAdvise clients on technology architecture, digital tools, system integrations, and evolutionary roadmapsMonitor KPIs, project progress, budgets, and the impact of implemented solutionsContribute to the definition of the digital portfolio and the development of new, high-tech servicesYou Are the Ideal Candidate If YouHave at least 7–10 years of experience in the Life Sciences sector, in technical or digital/IT transformation rolesHave worked in regulatory affairs, pharmacovigilance, QA, or clinical environments, preferably within pharmaceutical, biotech, or CRO organizationsHold a degree in Computer Science, Engineering, Bioengineering, Chemistry, or Pharmacy, with strong digital expertiseHave solid knowledge of RIM systems, eCTD, IDMP, digital platforms for regulatory and PV, API integrations, workflow automation, data governance, GxP, and EMA/FDA guidelinesHave at least 5 years of consulting experience, including client management and delivery of complex projectsThe Company OffersPermanent employment contractCompetitive salary and benefits packageFlexible working arrangements (full remote or hybrid options)Collaboration with multidisciplinary teams on international projectsOpportunities to contribute to business growth and the development of the digital offeringAll vacancies are open to candidates of all genders (Law ******).Please check whether this position is still open by visiting /#/ and entering the job reference code.You are welcome to submit your CV even if the selection process is closed, as we may contact you for future opportunities.Please read the privacy notice and provide consent for data processing in the application form.CPL & Taylor By Synergos SrlRicerca e Selezione del Personale - Aut.MLSPS Prot.13/I/*******Mantova – Parma – Verona – Modena – Brescia - CremonaCentralino Unico: ***************#J-*****-Ljbffr



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