Regulatory Affairs Assistant Bardi

Regulatory Affairs Assistant
Bardi
Emilia Romagna, Bardi

:

MILANO OFFICE

SPECIALIZZAZIONE:

Life Science

Our client, a global pharmaceutical company, is searching for a:

Regulatory Affairs AssistantBased 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

- Managethe appointment 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: