Regulatory Affairs and Pharmacovigilance Manager

Are you passionate about ensuring regulatory compliance and patient safety? Do you have experience in regulatory affairs and pharmacovigilance? We are looking for a Regulatory Affairs and Pharmacovigilance professional to join our team at Novo Nordisk. If you are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.

The position

As our new RA&PV manager your key focus is to provide strategic direction and scientific guidance in regulatory affairs across business areas (BA), aligned with the Novo Nordisk vision, values and policies and in accordance with Novo Nordisk BAGCEB (Greece, Central Europe & Baltic) strategies and business objectives. Lead the development of regulatory plans across the NN portfolio and their respective tactical implementations. Position based in Budapest. We are opened for candidates from EU, who wants to relocate to Hungary.

Your key accountabilities will be:

• Provide the solid ground to ensure the business areas functional governance of affiliates Regulatory team members across the BA, provide process support to optimise the regulatory operating models in terms of intelligence, life cycle management, labelling, policy follow-up and strategic health authorities’ engagement, and facilitate the development of talents across BAGCEB RA.
• Coordinate regulatory strategy implementation, process governance and information flow within BAGCEB according to the focus and priorities of business needs and global organisation, provide regulatory support to internal and external stakeholders on a BA level and act as an intermediary between the different affiliates, SEEMEA Regulatory Affairs.
• Support the overall pharmacovigilance activities and oversight in BAGCEB to ensure internal and external PV compliance with the ultimate objective of ensuring Patient Safety.
• Represent BAGCEB RA towards all regional & global counterparts and external stakeholders by taking active roles and leaderships in projects in line with the BA’s strategies and business objectives.
• Support of Pharmacovigilance activities to safeguard patient safety and compliance in BAGCEB – 100%

Qualifications

• Minimum 5 years’ working experience in Regulatory Affairs, licensing, drug development, preferably in EMA

  (European Medicines Agency) setting.

• To hold a Bachelor’s, Master’s/PhD degree in a relevant discipline – medicine, pharmacy, biology, chemistry or similar
• Cross cultural understanding, international mind-set and good networking/communication skills and ability to build internal and external networks are part of the job.
• Excellent command of written and spoken English and are able to travel (max 10% of time) to regional office/HQ.

About the Department

The department is known for its fast-paced and dynamic atmosphere. With a team of four dedicated professionals and the leading director, we strive to drive impactful initiatives and have influence in the medical field. We closely collaborate with market access and commercial teams at business area (BA) level and support medical/regulatory affairs functions in seven countries within the BA

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 50,000 employees. Together, we go further. Together, we’re life changing.

Contact

Please apply with your CV via the online recruitment system.

We thank all applicants for their interest, however only those candidates selected for interviews will be contacted.

Deadline

Please apply before 29.04.24

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.