Head Of Regulatory And Pharmacovigilance Lazio

Head Of Regulatory And Pharmacovigilance
Roma
Lazio, Lazio

Head of Regulatory 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 the Head of Regulatory and Pharmacovigilance for Italy and Malta. **The Position

- As Head of Regulatory and Pharmacovigilance you will guide the Regulatory and Pharmacovigilance team, directly reporting to our CMR (Clinical, Medical and Regulatory) 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 taking into account short, medium, and long term local business needs. - Among your main responsibilities:

- Ensure the Italian and Maltese regulatory and safety processes are in support of business goals and in compliance with relevant laws and regulations.

- Handle vendors' requests and demands on regulatory, quality, and safety information according to Novo Nordisk AS standards/SOPs.

- As Legislation List Monitor for Regulatory & Pharmacovigilance, perform documented impact assessment of new or revised local external requirements.

- Provide internal regulatory advice (gate keeping of marketed products) and coach team people about regulatory and pharmacovigilance tasks.

**Qualifications

- To be eligible for this role, you hold an Academic Degree in Biological Science, and you have an advanced level of English. - We also expect you to have:

- +10 years of pharmaceutical industry experience.

- 8-10 years of experience in Regulatory Affairs and/or Drug Safety.

- +5 years of People Management experience.

- a strong leadership attitude and the ability to inspire and influence people.

- passion and enthusiasm towards the field of activity.

**About the Department

- You will work in our Clinical, Medical and Regulatory (CMR) department at Novo Nordisk, that is one of the most diverse and collaborative groups within the organization. From health-care provider interactions and developing and implementing regulatory strategies, to providing medical education and collecting data to support efficacy and new product development, CMR is involved. **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. - We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. - At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.