Regulatory & Quality Affairs Lead — Pharma (Italy)

Ascendis Pharma; Milano; Ibrido; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global biotechnology company is seeking a Pharmaceutical Affairs Manager in Milan, Italy. The role involves ensuring compliance with Italian and EU regulations, overseeing pharmaceutical operations, and engaging with local authorities. The ideal candidate will have a degree in Pharmacy, at least 2 years of relevant experience, and strong communication skills. This position offers the chance to work in a supportive and dynamic environment, contributing to the safety and quality of medicines while collaborating with cross-functional teams across Europe.

Competenze

• Minimum 2 years of experience in Regulatory Affairs including Quality, Pharmacovigilance, or Distribution.
• Experience with AIFA interactions on different matters.
• Knowledge of EU GDP/GMP/GVP standards and quality systems.

Mansioni

• Oversee key regulated pharmaceutical activities including distribution, storage, import/export.
• Ensure compliance with Italian pharmaceutical laws and regulations.
• Act as the key point of contact for Italian authorities (AIFA).

Conoscenze

Knowledge of Italian pharmaceutical law

Strong English communication skills

Attention to detail

Collaborative teamwork

Formazione

Degree in Pharmacy or equivalent

Descrizione del lavoro

A global biotechnology company is seeking a Pharmaceutical Affairs Manager in Milan, Italy. The role involves ensuring compliance with Italian and EU regulations, overseeing pharmaceutical operations, and engaging with local authorities. The ideal candidate will have a degree in Pharmacy, at least 2 years of relevant experience, and strong communication skills. This position offers the chance to work in a supportive and dynamic environment, contributing to the safety and quality of medicines while collaborating with cross-functional teams across Europe.