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Regulatory Affairs Manager

hace 2 semanas

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We are looking for a Regulatory Affairs Manager to join our team at Exeltis. As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with safety-related regulations and overseeing global operational pharmacovigilance support for our R&D development candidates and marketed products.

Key Responsibilities:

  • Develop and implement safety protocols and procedures for clinical research studies.
  • Monitor the safety of clinical trial participants and ensure compliance with safety guidelines.
  • Collaborate with study clinical operation teams and Contract Research Organizations (CRO) personnel in audit readiness and preparation.
  • Review clinical research protocols and investigate any potential safety risks associated with the study.
  • Develop the development safety update report (DSUR) for clinical trials.
  • Analyse patient data to detect any changes in safety profiles.
  • Collaborate in the maintenance of the Quality PV system of Exeltis Organization, giving support in the elaboration, update, and implementation of Standard Operating Procedures (SOPs).

Requirements:

  • Education: Science (e.g. Pharmacy, Biochemistry, Biology) or medical degree.
  • Languages: Fluent in English verbally and in writing.
  • Experience (years / area): +3-5 years' experience with clinical trial operations and safety reporting in a pre and post marketing setting.
  • Specific Knowledge: Proficient knowledge of clinical trials regulations and safety reporting regulations under Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).
  • Travels: Minimal travel activity is expected.
  • Personal skills: Entrepreneurial, analytical skills, adaptability / flexibility, initiative, sociable, responsible.
  • Flexible start time from Monday to Friday (full-time).
  • Permanent contract.
  • Attractive salary package.