Regulatory Affairs Specialist

Are you detail-oriented and committed to ensuring regulatory compliance? Do you have experience in Regulatory Affairs? We are looking for a new Regulatory Affairs Specialist to join our team in Warsaw, Poland. If you are ready for a new challenge and want to make a difference in the healthcare industry, read on and apply today for a life-changing career.
The position
As a Regulatory Affairs Specialist, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA). You will ensure Regulatory Affairs compliance according to local legislation and Standard Operation Procedures (SOPs).
Your main responsibilities will include:

• Preparing and submitting Regulatory documentation for New Drug Applications, post-marketing variations and renewal applications to maintain Marketing Authorization of medicinal products.
• Translating and verifying Product Information of medicinal products and medical devices.
• Performing proofreading of labelling items and verifying promotional materials to ensure Regulatory Affairs compliance.
• Monitoring and interpreting current and changing pharmaceutical legislation and guidelines and building and maintaining good relationships with relevant internal and external stakeholders.
• Archiving Regulatory Affairs documentation and cooperating with and supporting the team within various Regulatory Affairs tasks and initiatives.

Qualifications
To be considered for this position you need to be accurate and detail oriented. You will be accountable and committed to the implementation of the assigned tasks and show ability to work independently and as part of a team. You are an excellent communicator with established time management skills.
Moreover, you will present:

• University degree, preferably within pharmacy/biology/chemistry or similar.
• Minimum 2-years' experience in Regulatory Affairs.
• Analytical skills and attention to details.
• Ability to work independently and as part of a team.
• Fluency in English (written and spoken), while proficiency in local language.

About the Department
Our Regulatory Affairs and Pharmacovigilance Team is responsible for all Novo Nordisk medicinal products and medical devices available in Poland. We are the integrated part of Clinical, Medical and Regulatory Department in Novo Nordisk Poland. As we share functions there is a strong collaboration between Regulatory and Pharmacovigilance functions and with regional/global teams. We are currently looking for a new colleague with a relevant scientific background who has a willingness to develop by being a part of our Team.
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.
Contact
Kindly send your CV online (click on Apply and follow the instructions). Internal Candidates are kindly requested to inform their line Manager when applying.
We thank all applicants for their interest, however, only those candidates selected for interviews will be contacted.
Deadline
Please apply by 6th October 2024.
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.