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 Company data:
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company name
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Novo Nordisk |
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introduction
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About Novo Nordisk Korea
Novo Nordisk Korea has established a strong foothold as a market leader which has
offered best solutions for people with diabetes, obesity, haemophilia and growth
hormones disorder for more than 30 years. The affiliate has been delivering double
digit sales growth year-on-year. Our sales growth stands-out in the market and within
Novo Nordisk. The affiliate is ranked among the top 15 within Novo Nordisk in term of
total revenue generated.
With our Ambition 2021(“Strive for Quality of Life for Everyone”), we have strived to
accelerate business growth, optimize organizational excellence, and attract and retain
the best talents. The team is proud of our achievement and strong team work, and is
excited about new product launches in coming years, which will be game changers in
market. We offer the great chance for you to be part of a great team, where passion
and engagement are met with opportunities for professional and personal development |
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Application method:
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Listing data:
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offer name
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(Sr.) Regulatory Affairs Associate |
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num of vacancies
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1 |
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keywords
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regulatory, regulatory affairs, RA |
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description
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This position reports directly to Regulatory Affairs Manager
The key responsibilities are as below:
- To register products in a timely manner in support of business and to maintain
full compliance of the products with regulatory requirements
- Preparation and submission of registration dossiers for NDA
- Provide regulatory input such as Regulatory timeline to the relevant functions
in terms of new projects
- Coordinate and facilitate new product registrations including GMP Review /
site inspection (PAI)
- To manage Product Life Cycle: Maintain regulatory compliance of locally registered
products in terms of CMC and Safety/Labelling updates and periodic GMP site
inspection
- To support the relevant functions such as promotional material review
- Preparing and coordinating new country specific labelling and follow-up the labelling
update
Degree of independent decisions
· Daily independent communication with MFDS, HQ and other teams/department with
regards to the tasks for the assigned products,which includes RA approval during
work process, document submission, etc. |
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profile
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Qualifications
A Pharmacist license holder
Has 4~7 years of work experience within the regulatory submissions/approvals
Possess strong verbal and written communication skills in both English & Korean
language
Regulatory experience in New Molecular area is highly preferred
Work experience in Global MNC (especially Matrix Organization) is a plus
Ability to adapt to the team and knows how to work and cooperate well with all the members
Has keen ability to organize, analyze data and identify issues
The job title of this position will be either RA Associate or Sr. RA Associate depending
on the experience level of the candidate.
This job is based in Seoul area covering all countries. |
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offer
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Attractive compensation and benefits
Work with diverse mutinational workforce
Chance to work in a globally competitive and world class pharmaceutical company |
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salary
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unspecified |
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Categorization data:
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region
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South Korea - Seoul |
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functions
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Others: Administrative Support & Secretarial |
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sectors
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Pharmaceutical Sector |
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contract type
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Permanent full-time |
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experience
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Mid-career |
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접수방법 및 기간
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 접수방법 : 홈페이지 접수
접수기간 : 2021년 1월 27일 (수) ~ 2021년 2월 26일 (금)
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