Regulatory Affairs Specialist
4 settimane fa
Regulatory Affairs Specialist
The chosen candidate, under general supervision responsible for the local coordination and the preparation of documents/packages for regulatory submissions, review and evaluate technical and scientific data and reports required for local submission in support of products.
Main responsibilities:
• Supports regulatory project plan execution • Maintain awareness of regulatory requirements and ensure continued learning • Maintain regulatory files in a format consistent with requirements • Participate as an active team member of project teams as required • Compile and prepare responses to questions from regulatory authorities according to plan • Edit and proofread regulatory documentation • Assist in preparation and review of labeling and other departmental documents • Compile under supervision regulatory documents for submission • Track status and progress of regulatory documentation • Prepare and review AdProm materials for compliance with local regulations • Understand Regulatory Affairs' position in small project teams
Required skills:
- Bachelor’s degree in a relevant scientific discipline - Regulatory experience preferably within a healthcare environment • Knowledge of regulations • Scientific knowledge • Administrative and project management skills • Ability to contribute to multiple projects from a regulatory affairs perspective • Ability to multitask and prioritize • Interpersonal and communication skills • Technical system skills (e.g. word processing, spreadsheets, databases, online research) • Proofreading and editing skills
Contractual and economic offer:
Fixed term contract until december 2024, a subsequent extension will be evaluated. Salary: CCNL Chimico Farmaceutico Liv.D1 / C2
From Monday to Friday / Full Time
Rome (EUR)
Lingue conosciute: Inglese
Competenze: Progettazione / Disegno tecnico - Microsoft Office
Disponibilità oraria: Full Time #J-18808-Ljbffr
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