Regulatory Compliance Specialist

Há 6 dias


Brasília, Distrito Federal, Brasil Chiesi Farmaceutici S.p.A. Tempo inteiro
About the Role

We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Chiesi Farmaceutici S.p.A. in Parma, Italy.

Main Responsibilities
  • Ensure quality compliance to pharmaceutical standards and internal procedures.
  • Guarantee regulatory compliance of production and analytical documents and processes to Global registration dossier.
  • Provide Global Products life-cycle regulatory support (i.e. CMC documentation review, deficiency letter responses, documentation for first registration).
  • Manage Global Products lifecycle quality activities (i.e. item codes attributes on SAP system, materials specifications on LIMS system).
  • Support life-cycle changes assessment and implementation phase.
  • Bridge activities between manufacturing plants (internal and external) and Global Regulatory Affairs.
Requirements
  • At least 4-5 years of experience in Regulatory or Quality Assurance positions in the pharmaceutical industry.
  • Degree in scientific disciplines (CTF, Chemistry, Biology, Pharmacy).
  • Fluent English (both written and spoken).
  • Knowledge of applicable national and international legislation (EMA, FDA, ICH guidelines, etc.).
  • Knowledge of reference pharmacopoeias monographs (EP, USP mainly).
  • Knowledge of GMP and Quality Systems.
  • Knowledge of AIFA regulations.
  • Knowledge of regulatory framework and registration dossier of MAH.
What We Offer
  • A dynamic, fast-growing, challenging and friendly environment.
  • Continuous training, learning and development opportunities.
  • A focus on quality of working environment and collective well-being.
  • A flexible working approach and remote working options.
  • Support in relocation process and tax assistance service for foreign colleagues.


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