Regulatory Affairs Manager
posted by: spj_bot
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
Support the enhancement of regulatory compliance and inspection readiness for clinical activities in Greece, with a focus on GCP and GDPR requirements. The role will provide local regulatory expertise and operational guidance to support teams ahead of a potential inspection by Greek health authorities.
Main Responsibilities:
- Provide expert guidance on Greek regulatory requirements for clinical trials and local health authority expectations.
- Advise internal teams on regulatory strategy and compliance matters.
- Share insights and lessons learned from clinical trial submissions to Greek authorities.
- Collaborate with local and global stakeholders on regulatory and operational topics.
- Assess regulatory and quality risks and support inspection readiness activities.
- Anticipate potential inspection findings and prepare responses to authority inquiries.
- Review clinical trial conduct, investigator site practices, and monitoring activities.
- Support deviation management, root cause analysis, and the development and implementation of CAPAs.
Requirements