Regulatory Assistant

23 hours ago

Athens, Attica, Greece Veeda Lifesciences Full time €45,000 - €55,000 per year

Veeda Lifesciences
is seeking a Regulatory Assistant based in Greece for its growing international hematology/oncology Clinical Trials program.

This is a full-time job.

Job overview:

The Regulatory Assistant (RA) provides support to regulatory department activities under the direction of the regulatory team members accountable, in collaboration with Veeda Lifesciences cross-functional teams and other in-country specialists (external or internal) involved in the submission activities. Assists with general administrative functions as required.

Main responsibilities:

  • Supports activities for regulatory / ethics fees' management and payment
  • Assists the regulatory team in the preparation, distribution and filing of the Clinical Trial Application and Amendments' documentation according to the scope of work and standard operating procedures
  • Supports with the update of the department's metrics or other tools, including the trial regulatory progress trackers & Smartsheet tools as applicable for the trials assigned
  • Assists on the regulatory section(s) of (e-)TMF updates for the assigned studies
  • Monitors CTIS for RFIs in EU countries, update the CTIS Log and inform the regulatory team accordingly upon an RFI receipt
  • Supports the regulatory team in the upload of submission documents for part I & part II, as well as of structured data in CTIS
  • Assists with the update of ICFs & other country trial essential documents such as patient facing documents upon amendments' release
  • Supports the arrangements of translation activities
  • May liaise and collaborate with the investigational sites for submission documents' collection or to support the submission activities performed from their side for the countries where this is applicable
  • Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection

Job Requirements:

  • Bachelor's degree, ideally in science or health-related field
  • Up to 1 year of experience in the field or equivalent experience. Prior experience in regulatory submission activities (CTIS) will be an asset.
  • Desirable: a) Research, health care related academic or industry work experience b) Awareness of applicable clinical research regulatory requirements i.e., GCP and International Conference on Harmonization (ICH) guidelines
  • Excellent command of English, both oral and written
  • Computer skills including good knowledge of MS Office (Word, Excel, and PowerPoint)
  • Good written and verbal communication skills
  • Good organizational skills
  • Ability to manage multiple tasks
  • Meticulous attention to detail
  • Effective time management
  • Ability to establish and maintain effective working relationships with co-workers, managers, and clients

Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment.

Competitive remuneration package comes on top.

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