Regulatory Affairs Specialist

Michael Page International Italia S.r.l.; Milano; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

Un'azienda farmaceutica leader cerca un Regulatory Affairs Specialist con almeno 5 anni di esperienza. Questa posizione offre l'opportunità di fornire input regolatori per lo sviluppo di nuovi prodotti e gestire le registrazioni a livello globale. La persona ideale avrà una laurea scientifica e preferibilmente un Master in Affari Regolatori. È richiesta una buona conoscenza delle normative farmaceutiche e un'ottima padronanza della lingua inglese. Se sei curioso, preciso e organizzato, questa è un'opportunità imperdibile per contribuire a progetti innovativi in un ambiente stimolante.

Competenze

• 5+ years of experience in Regulatory Affairs, preferably in Corporate roles.
• Strong knowledge of pharmaceutical laws and regulations in Italy and EU.

Mansioni

• Provide regulatory input for new products and manage product registrations.
• Support local marketing companies for fast product registration and lifecycle management.

Conoscenze

Regulatory Affairs

Pharmaceutical Laws and Regulations

Communication Skills

Curiosity

Organization

Teamwork

English Proficiency

Formazione

Scientific Degree (Pharmacy, Pharmaceutical Chemistry, Chemistry)

Master in Regulatory Affairs

Strumenti

eCTD Management

Descrizione del lavoro

Azienda

Our client, a leading pharmaceutical company, is looking for a Regulatory Affairs Specialist.

Offerta

Main Responsibilities of the role:

• Provide Corporate Regulatory input into the development of new products and due diligence initiatives.
• Obtain and maintain registration of company's new and existing products worldwide.
• Support local marketing companies (affiliates and distributors) to ensure fast product registration and good product life cycle management.
• Manage preparation of new regulatory documents, dossiers, and applications to enable products to be launched and maintained in market.
• Support key processes related to CMC, quality, labelling, artworks, and local regulations.
• eCTD management.
• Support the development of the strongest claims/advertising and promotion possible within the regulations, obtaining the required authorization.

Competenze ed esperienza

Qualifications & Skills

• Relevant previous experience of at least 5 years in Regulatory Affairs, preferably in Corporate roles.
• Good knowledge of pharmaceutical laws and regulations (Italy, EU countries, extra EU) and fluent management of the life cycle management.
• Scientific Degree (Pharmacy, Pharmaceutical chemistry, Chemistry, or related disciplines) and a Master in Regulatory Affairs is preferred.
• Good communication skills.
• Curiosity, precision, and organization.
• Ability to work autonomously or in a cross-functional team.
• Very good English proficiency.

Completa l'offerta

Great opportunity.