Senior Manager Regulatory Affairs and Pharmacovigilance

2 settimane fa

Roma, Italia Novo Nordisk A tempo pieno

Senior Manager Regulatory Affairs and Pharmacovigilance Join to apply for the Senior Manager Regulatory Affairs and Pharmacovigilance role at Novo Nordisk . 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? 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 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. 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 support business goals and comply 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 Your new department You will work in our LECQRA&PV department at Novo Nordisk, which 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 of 8 years of experience in regulatory affairs and pharmacovigilance within the 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 drive change. We’re a dynamic company in an even more dynamic industry, and 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 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. #J-18808-Ljbffr

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