Regulatory Affairs Specialist - EU&North America

Manpower; Firenze; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

Une entreprise pharmaceutique recherche un Spécialiste des Affaires Réglementaires pour son bureau à Florence. Le candidat gérera l'enregistrement de nouveaux produits et la maintenance des existants, collaborera avec des équipes internes pour des soumissions réglementaires. Ce rôle nécessite un diplôme en pharmacie ou domaines similaires et 3 ans d'expérience dans les affaires réglementaires internationales.

Competenze

• Minimum 3 years of experience in international pharma regulatory affairs.
• Fluent in English, both written and spoken.

Mansioni

• Planning and organizing activities for new product registration and maintenance.
• Collaborating with internal functions for regulatory submissions.
• Managing pediatric applications and updates.

Conoscenze

Organizational skills

Communication skills

Team-oriented

Proactivity

Formazione

Bachelor's degree in Pharmacy, Pharmaceutical Chemistry, Biology, Biotechnology, Chemistry

Descrizione del lavoro

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Regulatory Affairs Specialist - EU&North America, Florence

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Client:

Manpower

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

010a130c7ac1

Job Views:

9

Posted:

18.06.2025

Expiry Date:

02.08.2025

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Job Description:

Talent Solutions, part of Manpower Group, is currently recruiting for a REGULATORY AFFAIRS SPECIALIST for an important pharmaceutical client based in Florence. The role is within the Global Regulatory Affairs department - EU and North America area (EUNA). The specialist will work under the supervision of the EUNA Therapeutic Area Manager, managing a portfolio of products to ensure new registrations and maintenance of existing ones in the region.

MAIN ACTIVITIES AND RESPONSIBILITIES

• Planning and organizing activities for new product registration and maintenance through variations and renewals.
• Collaborating with internal functions (Quality Assurance, Medical, Marketing, Clinical, Pharmacovigilance) and external partners for regulatory submissions.
• Preparing master data packages for submissions to authorities.
• Managing pediatric applications and updates.
• Applying company procedures and monitoring regulatory changes in the area.

JOB REQUIREMENTS

• Bachelor's degree in Pharmacy, Pharmaceutical Chemistry, Biology, Biotechnology, Chemistry, or related scientific field.
• At least 3 years of experience in international pharma regulatory affairs.
• Fluent in English, both written and spoken.
• Proactive, dynamic, team-oriented, with strong organizational and communication skills.