Regulatory Affairs Specialist
3 settimane fa
**Tasks and Responsibilities**:
Revises promotional/informative/medical materials from a regulatory point of view according to Italian regulations and codes, and performs the submission to the authorities.
Transmits the promotional materials through the AIFA portal.
Gives support for diseases awareness materials/medical materials/press release/market research, and for SOP and technical specification drafting.
Performs training on Italian Regulation and codes to clients.
Performs the sales representative’s accreditation (communication to the regions + preparation of ISF cards + performs the foreseen activities in the online portals).
Manages the periodic communications to the Regions concerning sales representatives data, and manages sales representatives data transmission to AIFA.
Gives strategic support for marketing activities that can be requested by the clients.
**Essential Requirements**:
Degree in Pharmaceutical Chemistry and Technology, Pharmacy or similar.
Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
At least 3 years of experience in similar roles.
**Soft Skills**:
Communication and teamwork.
Attention to detail and organizational skills.
Time management and problem-solving.
Adaptability and resilience.
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