Senior Regulatory Affairs Specialist

(Sr.) RA Specialist

Regulatory Affairs

Seoul, Korea

Are you ready to redefine what regulatory affairs can achieve? At Novo Nordisk Korea, we are looking for a Senior Regulatory Affairs Specialist who thrives on turning complexity into opportunity. This is not just about compliance, it’s about shaping the future of healthcare by influencing strategies and accelerating access for patients. If you want to make an impact where science meets innovation, apply today and be part of something extraordinary.

Your new role

This permanent role reports to the Regulatory Affairs Manager and may be titled RA Specialist or Senior RA Specialist based on experience. You will ensure products enter and remain on the market with compliant claims aligned to commercial plans, while meeting all regulatory requirements. Acting as a key member of the local regulatory team, you will partner with stakeholders, represent Novo Nordisk to external bodies, and proactively drive improvements and regulatory strategies.

Other role tasks are as follows but not limited to:

• Lead the preparation of regulatory documents, dossiers, and applications to enable new products to be launched and maintained in the market, ensuring proper alignment and compliance with regulations while proactively seeking innovative and rapid paths to market.
• Analyze regulatory issues and communicate effectively with key stakeholders, including global colleagues. Develop and lead strategies and plans to mitigate risks, ensuring delivery of scientifically robust products aligned with business needs.
• Actively contribute to high performing teams, including looking for ways to improve performance. May lead cross-functional teams within local market.
• Build relationships with key stakeholders and represent Novo Nordisk in a responsible manner according to company values, in order to communicate Novo Nordisk policies and strategies and negotiate outcomes. Manage compliance within portfolio/activity streams in line with Novo Nordisk expectations. Propose solutions to identified issues and implement.
• Collaboratively work together with other functions (e.g., marketing, supply chain) to deliver NDA (New Drug Application) and value engineering projects. Support the development of the strongest claims and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
• Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business. Maintain required regulatory compliance databases, systems and processes.
• Train other company stakeholders as required to build knowledge and compliant utilisation. Maintain high level of knowledge on the science of products. Have daily independent communication with MFDS (Korean Ministry of Food and Drug Safety) and other teams/departments regarding the assigned tasks.

Your new department

You will be part of the Regulatory Affairs team at Novo Nordisk, a dynamic and collaborative group dedicated to ensuring regulatory compliance and patient safety. Our team plays a crucial role in gaining regulatory approval for clinical trials, new drugs, devices, and digital health solutions. We also work to expand the availability of existing products and shape future regulatory frameworks through dialogues with health authorities and policymakers. Based at our headquarters, you will join a fast-paced and innovative environment where your contributions will make a meaningful impact on patients' lives.

Your skills and qualifications

We are looking for a candidate who meets the following qualifications:

• Must hold a pharmacist license and has 5-10 years of work experience in the regulatory submissions/approvals.
• Work experience in new product registration and GMP inspection is a must.
• 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.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. 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.

Deadline

Until the completion of recruitment. There is a possibility that this job posting might be closed in the early stage depending on the volume of applications. 

 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.