Michael Andresini

PhD Synthetic Chemist | Scientific & Technical Documentation | Transitioning into Regulatory Affairs

Greater Paris Metropolitan Region

About

PhD in Drug Sciences with advanced training in pharmaceutical Regulatory Affairs, including regulatory submissions, variations, product lifecycle management, eCTD structure, and ICH quality guidelines. Combining a strong scientific background with extensive international experience in technical documentation and critical data analysis, I am pursuing RA opportunities in Rome to support regulatory activities throughout the medicinal product lifecycle. I bring 7+ years of experience in scientific writing, documentation review, and management of complex scientific data, ensuring accuracy and consistency of information while collaborating effectively across multidisciplinary and cross-functional teams. Through the scientific coordination of an EU-funded MSCA project, I have developed expertise in compliance-oriented project management, risk mitigation, and stakeholder communication within international environments.

Experience

  • CNRS (ICSN - CNRS - Université Paris-Saclay, Gif-sur-Yvette, Ile-de-France, Francia)
    • CDD Researcher – funded by Marie Skłodowska-Curie Actions
      May 2025 - Present · 1 yr 2 mos

      • Led preparation and submission of grant documentation, including compliance verification checklists • Ensured adherence to contractual and policy requirements (REA, Open Access, MSCA Green Charter) • Produced and reviewed technical documentation and analytical datasets • Managed data in accordance with the FAIR principles • Maintained structured, traceable project records ensuring audit readiness • Performed risk assessments and implemented mitigation strategies throughout project execution • Led project implementation, coordinating periodic reporting and internal project reviews • Ensured compliance with laboratory safety and quality standard • Collaborated with research teams and technical stakeholders • Supervised trainees (PhD, MSc)

    • CDD Researcher
      Jun 2024 - Present · 2 yrs 1 mo

      • Executed research activities under safety, quality, and timeline constraints • Identified risks and contributed to mitigation planning • Prepared technical reports and documentation for periodic project monitoring • Supported proposal drafting and project planning • Ensured timely delivery of milestones and deliverables • Performed structured data analysis and documentation review • Collaborated with external scientific partners • Supervised trainees (PhD, MSc)

  • Postdoctoral Researcher at Università degli Studi di Bari
    Jan 2023 - Jun 2024 · 1 yr 6 mos

    • Supported EU collaborative project (SusPharma) on sustainable pharmaceutical development • Prepared and reviewed technical documentation and structured reports • Coordinated activities across internal and external stakeholders • Ensured alignment with quality, safety, and efficiency requirements • Conducted structured data analysis and results interpretation • Reviewed trainee reports (PhD, MSc) ensuring clarity and technical accuracy • Contributed to team development by providing advanced training and mentorship • Contributed to dissemination and stakeholder communication activities

  • Research Assistant, PhD in Drug Sciences - Organic Chemistry at Università degli Studi di Bari & CNRS (DCM, Grenoble, France)
    Jan 2019 - Feb 2023 · 4 yrs 2 mos

    • Developed synthetic methodologies for pharmaceutically relevant compounds • Produced and reviewed technical documentation and experimental reports • Maintained structured datasets ensuring reproducibility and traceability • Performed impurity profiling and analytical characterization • Developed and optimized analytical and separation methods • Ensured compliance with laboratory safety and quality procedures • Supervised junior researchers and reviewed scientific documentation

  • Research Assistant at BCMATERIALS, BASQUE CENTER FOR MATERIALS, APPLICATIONS AND NANOSTRUCTURES
    Sep 2018 - Dec 2018 · 4 mos

    • Supported project monitoring through structured reporting • Contributed to research planning and led project execution • Managed scientific literature