Regulatory Affairs/Pharmacovigilance Professional

About The Department

The CMR Department at Novo Nordisk Estonia is responsible for ensuring regulatory compliance and patient safety. We work closely with regulatory agencies to gain approval for new products and expand the availability of existing products. Our team is dedicated to safeguarding patients and ensuring the safety of medicines throughout their lifecycle. We are a collaborative and dynamic department, driven by our mission to make a difference in the lives of patients worldwide.

Working at Novo Nordisk 

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing.

The Position

As a Regulatory Affairs/Pharmacovigilance Professional at Novo Nordisk, you will:Develop and maintain product registration, progress reports, supplements, amendments, and periodic experience reports. Ensure compliance with regulatory requirements and provide strategic product direction to teams.

• Interact and negotiate with regulatory agency personnel to expedite approval of pending registrations and respond to any questions. Maintain a controlled documentation system and record retention processes in accordance with regulatory requirements.
• Serve as a regulatory liaison on project teams throughout the product lifecycle and ensure regulatory impact assessments of production and label changes.
• Participate in the development of product plans, regulatory strategies, risk management, and implementation plans. Evaluate marketing materials.
• Ensure pre-clinical, clinical, CMC, device, and labeling documentation meet regulatory requirements and ensure rapid and timely approval of new drugs, biologics/biotechnology, and medical devices.

Qualifications:

To be successful in this role, we are looking for a candidate with the following qualifications:

Pharmacy Degree.

• Strong understanding of Regulatory Affairs and Pharmacovigilance.
• Fluency in both Estonian and English. 
• Capability to fulfill proof reading test requirements.
• Comprehensive knowledge of regulatory requirements and the ability to ensure compliance.
• Excellent communication skills.
• Highly driven with a keen eye for detail.
• Good organizational and time-management abilities.
• Ability to work effectively in cross-functional teams and navigate complex regulatory landscapes.
• Experience in developing and maintaining product registration documentation and interacting with regulatory agencies – would be an advantage.
• Experience in the pharmaceutical industry or a regulated environment is preferred.

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.