* 회사 소개

저희 노보 노디스크제약(주)는 덴마크 코펜하겐을 본사로 둔 글로벌 제약사로, 한국 지사의 경우 사원수 210명 (현재 기준), 매출액 1,651억 7,834만원 (2019년 12월 기준) 규모의 외국계 제약사입니다.

송파구 잠실에 위치하고 있으며, 당뇨 관리 제품, 비만치료, 혈우병 관리 제품, 성장 호르몬 치료사업을 하고 있습니다.

[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 ''document''s, 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 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, HQ and other teams/department regarding the tasks for the assigned products, which includes RA approval during work process, ''document'' submission, etc.

[Job Requirements]

*     Pharmacist license holder is a must and has 4+ years of work experience with the regulatory submissions/approvals

*     Regulatory experience in Global MNC 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

* 문의처 : IMKZ@novonordisk.com, YLKM@novonordisk.com

* 지원링크 : https://www.novonordisk.com/content/nncorp/global/en/careers/find-a-job/job-ad.251121.en_GB.html