Regulatory Affairs Consultant

JR Italy; Genova; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• Experience in regulatory affairs and submissions.
• Familiarity with local regulatory requirements.
• Ability to manage multiple regulatory tasks.

Mansioni

• Prepare and submit local regulatory documentation.
• Support Marketing Authorization Applications and post-approval activities.
• Maintain and update regulatory systems.

Conoscenze

Regulatory Compliance

Regulatory Submissions

Local Regulatory Intelligence

Strumenti

Veeva Vault RIM

Descrizione del lavoro

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Position: 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 Authorization 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.