Senior Regulatory Affairs Specialist

4w4 weeks ago

Novo Nordisk

Seoul, KR · Full-time

About this role

Are you ready to redefine what regulatory affairs can achieve? At Novo Nordisk Korea, we are seeking a Senior Regulatory Affairs Specialist who thrives on turning complexity into opportunity. This role is about shaping the future of healthcare by influencing strategies and accelerating patient access.

You will lead the preparation of regulatory documents, dossiers, and applications to launch and maintain products in the market. Daily work includes analyzing regulatory issues, communicating with global colleagues, and developing strategies to mitigate risks while ensuring scientifically robust products aligned with business needs.

You will join a dynamic and collaborative Regulatory Affairs team dedicated to gaining approval for clinical trials, new drugs, devices, and digital health solutions. Based at our headquarters in Seoul, you will engage with the MFDS (Korean Ministry of Food and Drug Safety) and other stakeholders to shape future regulatory frameworks.

This permanent role offers the opportunity to make a meaningful impact on patients' lives. Whether titled RA Specialist or Senior RA Specialist based on experience, you will partner with cross-functional teams and external bodies to drive improvements and accelerate market access.

Requirements

Experience in regulatory affairs within the pharmaceutical or life sciences industry.
In-depth knowledge of Korean pharmaceutical regulations and MFDS submission processes.
Ability to analyze complex regulatory issues and develop proactive risk-mitigation strategies.
Strong stakeholder management and negotiation skills, with experience representing a company to external bodies.
Proven ability to lead or contribute to cross-functional teams and drive regulatory projects.
Familiarity with new drug applications (NDA) and value engineering in a regulatory context.

Responsibilities

Lead preparation of regulatory documents, dossiers, and applications to enable new product launches and market maintenance, ensuring alignment and compliance with regulations.
Analyze regulatory issues and communicate effectively with key stakeholders, including global colleagues, to develop strategies that mitigate risks.
Actively contribute to high-performing teams, identifying ways to improve performance and potentially leading cross-functional teams within the local market.
Build relationships with key stakeholders and represent Novo Nordisk externally to communicate policies, strategies, and negotiate outcomes.
Collaborate with functions like marketing and supply chain to deliver NDA and value engineering projects, supporting development of strongest claims within regulations.
Proactively identify potential regulatory risks and manage the impact of regulatory changes on the business, maintaining required compliance databases and systems.
Train other company stakeholders as needed to build knowledge and compliant utilization, maintaining a high level of product science understanding.
Have daily independent communication with MFDS and other teams/departments regarding assigned tasks.

Benefits

Opportunity to work at a global leader in pharmaceutical innovation.
Be part of a collaborative and dynamic regulatory affairs team in Seoul.
Role with direct impact on patient access to life-changing therapies.
Possibility to shape regulatory frameworks through engagement with health authorities.