Novo Nordisk

(Sr.) Regulatory Affairs Associate

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공고번호 : 19078268
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    담당업무
    (Sr.) Regulatory Affairs Associate
해당 채용공고는 마감 되었습니다. - 채용공고접수기간이 마감되어 더 이상 입사지원을 하실 수 없습니다. 채용에 관련된 내용은 아래 상세모집요강 및 담력(談力)시리즈에서 확인 하실 수 있습니다. 본 채용공고에 입사지원을 했거나 관심있는 구직자를 위해 일정기간 노출 후 비공개될 예정입니다.

상세모집요강

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 https://stats.the-network.com/redirect/511f6cc9-4508-41d0-bf78-ce926da0e8b6

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

접수방법 및 기간
 접수방법 : 홈페이지 접수
 접수기간 : 2021년 1월 27일 (수) ~ 2021년 2월 26일 (금)

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