Senior Manager Regulatory Affairs and Pharmacovigilance

Senior Manager Regulatory Affairs and Pharmacovigilance

Category: Reg Affairs & Safety Pharmacovigilance

Location:Roma, Lazio, IT

Do you have a solid experience in regulatory and pharmacovigilance fields? Do you want to take your career path to the next level, in one of the leading companies of the pharma sector?

If it sounds interesting to you, we have the right job

The Italian affiliate of Novo Nordisk, based in Rome, is hiring for the position of Senior Manager Regulatory Affairs and Pharmacovigilance (RA&PV) for Italy and Malta.

Your new Role

As Senior Manager Regulatory Affairs and Pharmacovigilance you will guide the Regulatory Affairs and Pharmacovigilance team, directly reporting to our LECQRA&PV (Legal, Ethics, Compliance, Quality, Regulatory & Pharmacovigilance) Director.

You will supervise all regulatory and safety operations of the company, in full compliance with corporate and legal requirements, and you will support new business opportunities and strategic objectives considering short, medium, and long term local business needs.

Among your main responsibilities:

• Lead the RA&PV team, setting objectives and development plans
• Build regulatory advocacy strategies to influence policy and maintain strong relationships with authorities.
• Ensure the Italian and Maltese regulatory and safety processes are in support of business goals and in compliance with relevant laws and regulations.
• Oversee collection, assessment, and reporting of adverse events and safety cases.
• Coordinate preparation and review of promotional materials in compliance with regulations.
• Manage internal audits and regulatory inspections.
• As Legislation List Monitor for Regulatory Affairs & Pharmacovigilance, perform documented impact assessment of new or revised local external requirements.
• Provide internal regulatory advice to the line of business.

For this position, we are looking ideally for someone based in Rome, or available to relocate nearby.

Your new department

You will work in our LECQRA&PV (Legal, Ethics, Compliance, Quality, Regulatory & Pharmacovigilance) department at Novo Nordisk, that is one of the most diverse and collaborative groups within the organization.

Qualifications

To be eligible for this role, you must hold an Italian Academic Degree in scientific disciplines (Pharmacy, Chemistry, Biology) or equivalent, coupled with a minimum 8 yrs of experience in regulatory affairs and pharmacovigilance preferably, within pharmaceutical industry:

We also expect you to have:

• +5 years of People Management experience
• Bold leadership attitude and the ability to inspire and influence people.
• Passion and enthusiasm towards the field of activity.
• Fluent English and Italian, both written and spoken

Working at Novo Nordisk

At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we're all working to move the needle on patient care.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

More information

If you believe you are qualified, and cannot wait to take the challenge, please upload your CV directly via our online application tool.

Deadline

Apply before the 10th of December.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.