Regulatory Affairs Specialist
2 settimane fa
Meditrial Europe Ltd. is a leading clinical research organization dedicated to delivering unparalleled outcomes for innovators in the lifescience industry.
As a Regulatory Affairs Manager, you will oversee the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions.
The position will support and/or drive strategic regulatory strategies for multiple projects together with subject matter experts.
Key Responsibilities:- Management of CTD (Electronic Common Technical Document)
- Collaboration during implementations of regulatory strategies for New MA through National/Decentralized/Centralized Procedures
- Preparing submissions of variations type I, II, Renewals, and Safety variations
- Management of CMC activities (updating module III of ECTD)
- Collaboration during the Management of Recall
- Creation and updates of Technical File (TF)
- Relationship with manufacturers
- Interface with pharmaceutical databases
- Review and submission of promotional materials
- Support of clinical investigations
- Management of Medical Device Post-marketing and Surveillance Medical Devices activities
- Notification of new Food Supplements and changes to Ministry of Health
- Supervision of International Regulatory and Quality activities
- Master's Degree in science or related field, Doctor of Medicine MD is a plus
- Thorough experience in life-science field and Regulatory Affairs
- Proficiency in oral and written English and Italian (third language is a plus)
- Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, MS Power Point)
- Excellent communication, planning, and organizational skills
- Demonstrated ability to handle multiple competing priorities
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