Position

Regulatory Affairs Associate Manager

Job description

Job description

Location

Seoul, South Korea

Job category

Regulatory

 

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

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

 

About the Department

 

The Clinical Medical and 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 title of this position is to be decided based on the candidate's experiences, and the title would be Sr. Specialist - Associate Manager level based on the qualifications. This position reports directly to Regulatory Affairs & Pharmacovigilance Head.

 

The Position


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, be a productive part of 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 market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market, analyse 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, build relationships with key stakeholders and represent Novo Nordisk in a responsible manner according to company values, to communicate Novo Nordisk policies and strategies and negotiate outcomes, and manage 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 impact of regulatory changes within defined scope of responsibility on the business, and Understanding of RA structure & local regulations.
  • Maintain required regulatory compliance databases, systems and processes, and high level of knowledge on the science of products within defined portfolio, and have daily independent communication with MFDS (Korean Ministry of Food and Drug Safety), other teams/department regarding the tasks for the assigned products, which includes RA approval during work process, document submission, etc.

 

Qualification  

  • Pharmacist license holder is a must and has 4+ years of work experience with the regulatory submissions/approvals 
  • Regulatory experience in Global multi-national company is a plus
  • The title of this position is to be decided based on the candidate's experiences, and the title would be Sr. Specialist - Associate Manager level based on the qualifications
  • Have time management skills, has 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 change. 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. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases.

 

 

Contact

 

Please click on the link to apply

 


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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