Regulatory Affairs Consultant

JR Italy; Frosinone; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading company is seeking a Freelance Regulatory Affairs Consultant for a 12-month contract based in Frosinone, Italy. The role involves preparing regulatory documentation, supporting marketing applications, and ensuring compliance with local regulations. Ideal candidates will have strong experience in regulatory affairs and familiarity with local systems.

Competenze

• Experience in regulatory submissions and local compliance.
• Ability to manage multiple regulatory tasks and documentation.
• Familiarity with local regulatory systems.

Mansioni

• Prepare and submit local regulatory documentation.
• Support Marketing Authorisation Applications and post-approval activities.
• Maintain Veeva Vault RIM and handle regulatory fee calculations.

Conoscenze

Regulatory documentation preparation

Regulatory compliance

Regulatory intelligence

Strumenti

Veeva Vault RIM

Descrizione del lavoro

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Regulatory Affairs Consultant, Frosinone

Client: Discover International

Location: Frosinone, Italy

Job Category: Other

EU work permit required: Yes

Job Reference: 558163766420701184337162

Job Views: 2

Posted: 22.05.2025

Expiry Date: 06.07.2025

Job Description:

Freelance Regulatory Affairs Consultant (0.5 FTE, 12-Month Contract)

Locations: Italy, Switzerland, Germany

Engagement: Freelance / Independent Consultant

Duration: 12 months (max 0.5 FTE)

Start: ASAP

Key Responsibilities

Regulatory Submissions & Maintenance:

• Prepare, update, and submit local (country-level) regulatory documentation (SPC, PIL, abbreviated PI, PSURs, renewals, variations, etc.).
• Support local Marketing Authorisation Applications (MAAs) and manage post-approval activities.
• Update and approve local product artworks and country label deviations.
• Ensure compliance with CCDS and local regulatory requirements.

Operational Support:

• Maintain and update Veeva Vault RIM and local regulatory systems.
• Handle regulatory fee calculations, payment requests, and Change Control procedures.
• Provide local regulatory intelligence and support SOP review and updates.