Regulatory Affairs Consultant

JR Italy; Pisa; In loco; EUR 40.000 - 70.000; Part-time

Descrizione del lavoro

A leading company in the pharmaceutical industry is seeking a Freelance Regulatory Affairs Consultant for a 12-month contract. The role involves preparing and submitting regulatory documentation, ensuring compliance with local requirements, and providing operational support. Ideal candidates will have a strong background in regulatory affairs and experience with local market regulations.

Competenze

• Experience in preparing and submitting regulatory documentation.
• Knowledge of local regulatory requirements in Italy.
• Ability to manage multiple regulatory projects simultaneously.

Mansioni

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

Conoscenze

Regulatory Compliance

Documentation Management

Regulatory Intelligence

Formazione

Degree in Life Sciences or related field

Strumenti

Veeva Vault RIM

Descrizione del lavoro

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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.