Regulatory Affairs Associate (1year contract)

Are you passionate about ensuring regulatory compliance for new products and product amendments? Do you thrive in a fast-paced environment and enjoy working with key stakeholders to navigate regulatory frameworks? If so, we have an exciting opportunity for you to join our team as a Regulatory Affairs Associate at Novo Nordisk Korea. Apply today for a life-changing career.
About the department
The Clinical, Medical, Regulatory (CMR) department is one of the key functions that enable the business strategy through effective execution of functional goals, in the areas of Clinical Research, Medical Affairs, and Regulatory. The department works closely with health authorities and policymakers to shape future regulatory frameworks. Additionally, the department plays a crucial role in safeguarding patient safety by collecting, analyzing, and reporting safety data. Join our team and contribute to our mission of delivering safe and effective healthcare solutions.
The position
As a Regulatory Affairs Associate, you will ensure products can be placed on the market with optimal yet compliant claims, and promotion in line with commercial plans, ensure products are maintained and meet internal and external compliance requirements. You will be a productive part of a local regulatory team, including being a proactive partner to other stakeholders, engage with the external regulatory environment and act as the voice of Novo Nordisk Korea with local regulators, trade associations and other key external regulatory bodies. The role will also work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges.
The role tasks include but are not limited to:

• Prepare new regulatory documents, dossiers, and applications to enable new products to be launched and maintained in the market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market, assess regulatory issues and convery effectively with key stakeholders, including global colleagues. Develop strategies and plans to address, so that we can deliver products backed by science that are robust and aligned with business needs.
• Actively contribute to high-performing teams, including looking for ways to improve performance, building relationships with key stakeholders, and representing Novo Nordisk in accordance with company values. Communicating Novo Nordisk policies and strategies, negotiating outcomes, and managing compliance within portfolio/activity streams in line with Novo Nordisk.
• Collaborate with other functions (e.g., marketing, supply chain) to deliver approved New Drug Application (NDA) and value engineering projects, and aid in the development of the strongest claims and promotion possible within the regulations, ensuring risks are appropriately addressed and conveyed.
• Proactively identify potential regulatory risks and manage the impact of regulatory changes.
• Maintain required regulatory compliance databases, systems and processes, and high level of knowledge on the science of products, and have daily independent communication with MFDS (Korean Ministry of Food and Drug Safety), and other teams/departments regarding the tasks for the assigned products, which includes RA approval during work process, document submission, etc.

Qualifications

• Must hold a pharmacist license.
• Regulatory experience in a multinational company is a plus.
• Possesses strong time management, analytical thinking, and problem-solving skills.
• Demonstrates a good command of English and exhibits persuasive and impactful communication.

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 upload your CV to our online career page (click on Apply and follow the instructions).
Deadline
Until the completion of recruitment.
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
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.
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