

Regulatory affairs professional with deep expertise in compliance, regulatory submissions, and quality assurance. Skilled in navigating complex regulatory landscapes, ensuring adherence to industry standards, and driving successful outcomes. Strong team player, adaptable to changing needs, and focused on delivering results through collaboration, communication, and problem-solving. Adept at leveraging analytical skills and regulatory knowledge to support organizational goals.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
Familiarity with Veeva VaultRIM and eRDMS systems
Understanding of eCTD format and CMC documentation
Strong data management and reporting skills
Knowledgeable in regulatory software such as LorenZ, Trackwise, etc
Proven ability to maintain up-to-date knowledge of national and European guidelines/legislation
Excellent organizational and communication skills
Proactive attitude
Ability to work independently
Ability to work collaboratively within a team environment
Capacity to prioritize tasks effectively
Manage multiple workloads
Meet tight deadlines
Personal dedication to maintaining a high standard of work
Familiarity with lifecycle maintenance processes
Familiarity with post-approval applications
Familiarity with compliance requirements