Company data:
company name Novo Nordisk
introduction 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

Application method:
application link

Listing data:
offer name (Sr.) Regulatory Affairs Associate
num of vacancies 1
keywords regulatory, regulatory affairs, RA
description 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
- To support the relevant functions such as promotional material review
- Preparing and coordinating new country specific labelling and follow-up the labelling

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.
profile 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
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.
offer Attractive compensation and benefits
Work with diverse mutinational workforce
Chance to work in a globally competitive and world class pharmaceutical company
salary unspecified

Categorization data:
South Korea - Seoul
functions Others: Administrative Support & Secretarial
sectors Pharmaceutical Sector
contract type Permanent full-time
experience Mid-career

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 Ⱓ : 2021 1 27 () ~ 2021 2 26 ()

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