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Regulatory Affairs Specialist
4 mesi fa
Adecco Italia Spa – Branch Roma Ovest, for a prestigious multinational of pharmaceutical chemical sector, is looking for a
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
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