SENIOR DIGITAL REGULATORY CONSULTANT LIFE SCIENCES

CPL & Taylor by Synergos Srl; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading consulting company is seeking a Senior Digital Regulatory Consultant for a remote role in Italy. Candidates should have 7-10 years of experience in Life Sciences and expertise in regulatory affairs and digital IT transformation. Responsibilities include leading the design of regulatory systems, coordinating teams, and advising clients on technology solutions. The position offers a permanent contract with competitive compensation and flexible working options, along with involvement in international projects.

Servizi

Competitive salary and benefits package

Flexible working arrangements

Opportunities for professional development

Competenze

• 7-10 years of experience in the Life Sciences sector, focused on technical or digital transformations.
• Experience in regulatory affairs, QA, or clinical environments within pharmaceuticals or biotech.
• Strong knowledge of EMA/FDA guidelines and GxP standards.

Mansioni

• Lead the design and implementation of digital regulatory systems.
• Coordinate technical and functional teams to meet project requirements.
• Advise clients on technology architecture and digital tools.
• Analyze regulatory processes to identify areas for digital transformation.

Conoscenze

Digital expertise

Regulatory knowledge

Project management

Client management

Formazione

Degree in Computer Science, Engineering, Bioengineering, Chemistry, or Pharmacy

Strumenti

RIM systems

eCTD and IDMP tools

Digital platforms for regulatory and PV

Descrizione del lavoro

CPL & TAYLOR by Synergos is recruiting:

SENIOR DIGITAL REGULATORY CONSULTANT

LIFE SCIENCES

(Ref. ANN417621)

Location: full remote

Contract: Permanent, full-time

Compensation: To be defined based on experience

The 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.

The Role

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.

Key Responsibilities

• 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

You Are the Ideal Candidate If You

• 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

The Company Offers

• 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).

Please check whether this position is still open by visiting https://cpltaylor.it/annunci/#/ 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.

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CPL & Taylor By Synergos Srl

Ricerca e Selezione del Personale - Aut. MLSPS Prot.13/I/0008775

Mantova – Parma – Verona – Modena – Brescia - Cremona

Centralino Unico: [phone]