Regulatory Affairs Specialist

:
MILANO OFFICE
SPECIALIZZAZIONE:
Life Science
Our client, a global pharmaceutical company, is searching for a:
Regulatory Affairs specialist Based in Milan The Regulatory Assistant works within the Market Access Department and is responsible to support the Pricing & Reimbursement & Regulatory Manager for the regulatory activities.
The job-holder will maintain product licenses held by the company at local level and could interact with National/Local Regulatory Authorities.
He/she ensures a regular update on the new National/Local regulatory aspects.KEY RESPONSIBILITIES & DECISIONS:
- Check of the promotional/disease awareness/no promotional materials proposed by Marketing/ Medical/Access functions
- Check of Market research (absence of promotional elements)
- Check the artworks sent by Head Office
- QC Linguistic review of documents sent by Head Office
- Verify the compliance, from the regulatory point of view, of the requirements provided by national and regional regulations
- Manage theappointment of ISF at regional/local level
- Communication about ISF activities to regional/national authorities
- Management of database maintenance such as CODIFA, Farmastampati / Farmadati, Unifarm etc.
Ensures constant updating regarding new national regulations in the regulatory field.
Interact with the competent authorities for some regulatory aspects
- Support the teams on regulatory aspects REQUIREMENTS:
- Scientific degree
- One year of experience in the Regulatory Departments of pharmaceutical companies - Fluent in English Location: