Regulatory and Pharmacovigilance Lead for Italy and Malta

4 ore fa


Roma, Lazio, Italia Novo Nordisk A tempo pieno

**Job Overview**

We are seeking a highly experienced Regulatory and Pharmacovigilance Lead to join our team in Rome, Italy. As a key member of our Clinical, Medical and Regulatory (CMR) department, you will be responsible for guiding the Regulatory and Pharmacovigilance team and ensuring compliance with corporate and legal requirements.

**About the Role**

The successful candidate will have a strong background in pharmaceutical industry experience, specifically in Regulatory Affairs and/or Drug Safety. You will be responsible for supervising all regulatory and safety operations, handling vendors' requests, and providing internal regulatory advice. Additionally, you will coach team members on regulatory and pharmacovigilance tasks.

**Key Responsibilities**

- Ensure Italian and Maltese regulatory and safety processes support business goals and comply with relevant laws and regulations.
- Handle vendors' requests and demands on regulatory, quality, and safety information according to Novo Nordisk AS standards/SOPs.
- Perform documented impact assessments of new or revised local external requirements as Legislation List Monitor for Regulatory & Pharmacovigilance.
- Provide internal regulatory advice (gate keeping of marketed products) and coach team people about regulatory and pharmacovigilance tasks.

**Requirements**

To be eligible for this role, you must hold an Academic Degree in Biological Science and have an advanced level of English. We expect you to have at least 10 years of pharmaceutical industry experience, 8-10 years of experience in Regulatory Affairs and/or Drug Safety, and +5 years of People Management experience. A strong leadership attitude and ability to inspire and influence people are also essential.

**Benefits**

As a valued member of our team, you can expect a competitive salary of around €85,000 per annum, depending on your qualifications and experience. Our company offers a dynamic and inclusive work environment, opportunities for professional growth, and a chance to make a meaningful impact in the lives of patients.



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