[노보노디스크제약] Regulatory Affairs Associate (1년 계약직) 채용

 회사 소개

노보노디스크 제약의 본사는 덴마크 코펜하겐에 위치해있으며, 당사는 인슐린 전달 시스템 분야의 가장 발전된 제품 생산과 함께 이 업계에서 가장 광범위한 당뇨 제품 포트폴리오를 갖추고 있는 당뇨 치료제의 세계적인 리더입니다. 또한 노보노디스크는 당뇨 치료제 뿐만아니라, 비만치료제 및 혈액 응고장애, 성장 장애 제제등과 관련된 호르몬 대체요법 분야에서도 선도적인 위치를 차지하고 있습니다. 현재 노보노디스크는 전세계 75개국에 55,000명 이상의 직원들이 근무하고 있으며, 한국 노보노디스크는 약 280명, 매출액 2,190억원 규모의 회사입니다. (사무실 위치: 송파구 잠실) 현재 당뇨 분야 외에 비만치료, 혈우병, 성장 호르몬 영역에 이어 알츠하이머 및 다양한 치료 영역의 제품이 임상 후반부에 있습니다.

지속적인 혁신과 개발을 바탕으로, 빠르게 성장하고 있는 글로벌 제약사에서 함께 일할 능력있는 인재를 찾고 있습니다. 

About the Department

Within our Regulatory Affairs Team, we have now 7 team members who use our skills, dedication and ambition to achieve our team’s goal. Now we’re looking for competent (Sr.) RA Associate who will bring more synergy to the company. In exchange, we offer the chance to be part of a highly specialized business in a global healthcare company, with respectful cultures and balanced work environment.

The Position

This position has been newly created with the support of International Operations (IO) funding as part of the team expansion.

The title of this position is to be decided based on the candidate's experiences, and the job title would be RA Associate - Sr. RA Associate based on the qualifications.

This position reports directly to Regulatory Affairs & Pharmacovigilance Head.

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, analyze 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.

Job Requirements

• Pharmacist license holder is a must
• Work experience with the regulatory submissions/approvals is a plus
• Regulatory experience in multi-national company is a plus
• Have time management skills, have analytical thinking, and can solve problems effectively
• Good command of English, and is persuasive and impactful 

문의처 : IMKZ@novonordisk.com

전형방법

1차 서류 전형

2차 폰스크린 전형

3차 면접 전형 (상세는 개별 해당자에게 연락)

지원링크 : https://careers.novonordisk.com/job-invite/288006/ 에 자유양식의 

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