Are you highly motivated by being able to make a difference in improving patients’ lives? Are you a high-performing executive who is energized by challenges and able to energize people around you? If so, you should continue reading and apply now!

In Novo Nordisk Korea, the position of (Sr.) Regulatory Affairs (RA) Specialist provides you the opportunity to work in a high-performing team to contribute directly towards the business results while creating value for Diabetes patients.

About the department

Within our Regulatory Affairs Team, we have now 7 team members who use our skills, dedication and ambition to achieve our team’s goal. Now we’re looking for competent (Sr.) RA Specialist who will bring more synergy to the company. In exchange, we offer the chance to be part of a highly specialized business in a global healthcare company, with respectful cultures and balanced work environment.

The position

This position has been newly created as part of the team expansion and will report directly to the Regulatory Affairs & Pharmacovigilance Head.

The job title of this position will be either RA Specialist or Sr. RA Specialist depending on the experience level of the candidate. This position is permanent.

The successful candidate will ensure products can be placed on the market with optimal yet compliant claims, advertising, 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 defined local regulatory team, including being a proactive partner to other stakeholders, engage with the external regulatory environment within defined area of accountability 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 are as follows but are not limited to:

• Lead preparation of 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, analyze regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and plans to mitigate, 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 responsibly representing Novo Nordisk according to company values. Communicating Novo Nordisk policies and strategies and negotiate outcomes, and managing compliance within defined portfolio/activity streams in line with Novo Nordisk.
• Collaborate with other functions (e.g., marketing, supply chain) to deliver agreed NDA (New Drug Application) and value engineering projects, and aid in the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
• Proactively identify potential regulatory risks and manage the impact of regulatory changes within the defined scope of responsibility on the business, and understanding of RA structure and local regulations.
• Maintain required regulatory compliance databases, systems and processes, and high level of knowledge on the science of products within a defined portfolio, 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

• Pharmacist license holder is a must
• Has 4+ years of work experience in the regulatory submissions/approvals
• Work experience in new product registration and manufacturing site transfer is a must
• Regulatory experience in multi-national company is a plus
• Has time management skills, have analytical thinking, and can solve problems effectively.
• Good command of English, and is persuasive and impactful.

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). Internal candidates are requested to inform their line manager when applyin.

Deadline

Until the completion of the 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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