[한국베링거인겔하임] RA Specialist (contractor)
Tasks
THE POSITIONRA Specialist (Contractor) is responsible for preparing and submitting regulatory documents, maintaining product compliance, and liaising with regulatory authorities to support product approval and lifecycle management ensuring that a company's products comply with all relevant regulations and guidelines throughout their lifecycle.
Contract will be ended in September 2027
RA activities support for the below tasks 1. Product Registration & Registration Maintenance - Achieve timely & successful product registrations in accordance with corporate & local strategies - Manage all the regulatory tasks & projects, including attaining, maintaining product licenses and operation licenses on behalf of BI as required by local regulations - Compile registration applications for new products and variations to marketed products - Monitor progress of submissions & coordinate timely responses to all questions from the Regulatory Authorities. - Be Compliant with Corporate policies, principles & procedures, in particular implementation of current Company Core Data Sheet (CCDS), Chain Review Committee (CRC) and local change control procedures. 2. Regulatory Intelligence - Collect any information on new Regulations and Guidelines, and to share it in local RA team - Be responsible to collect the up-to-date information on local regulation via internet searching & communication with colleagues in other pharmaceutical companies 3. Business support - Provide regulatory consultation & collaborate with local business partners (e.g., Medical Affairs, Market access, PM/Sales and etc.) 4. Compliance - Ensure compliance with Company regulatory policies, principles & procedures - Ensure that regulatory database is up to date to reflect the current registration status or regulatory requirements (e.g., CPD3, RequireBASE or other information sources) 5. Regulatory interaction - Communicate with Regulatory Authorities and local industry groups on regulatory issues |
Requirements
Requirements
ㆍRA experience in pharmaceutical industry for more than 3 years (Preferably RA experience from multinational pharmaceutical companies for drug registrations for chemical / oncologic / biologic pharmaceutical products and/or for rare disease treatment)
ㆍBachelor’s degree in pharmacy and/or Professional Training
ㆍKnowledge of local and international regulatory affairs regulation
ㆍFluent in Korean
ㆍGood organizational and communication skills, active and diligent attitude
ㆍFluent English skill in reading/writing/speaking
ㆍKnowledge & Insight in the local pharmaceutical regulation & industry
ㆍAbility and confidence to communicate professionally with Regulatory Authorities and other external and internal people
ㆍLearning agility
Information
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The Others
지원서는 들어오는 순서대로 확인할 예정이며 입사지원 서류에 허위사실이 발견될 경우, 채용이 취소될 수 있습니다. 또한, 서류 합격자에 한하여 안내가 나갈 예정이오니 참고 부탁드립니다.
Ai Keywords
경력 수준
근무 지역
직종
업종
주요 업무
자격 요건
우대 사항
채용 요약
Company
한국베링거인겔하임은 1976년 독일과 합작투자하여 태어난 글로벌 기업으로서, 천연의약품 분야에서 생물의약품 분야에 이르기까지 수많은 우수 의약품을 국내에 소개하면서 국내 의약업계의 진정한 동반자로서 함께 해오고 있습니다. 앞으로도 한국베링거인겔하임은 인간의 생명과 이 땅의 환경을 소중히 여기며, 삶의 질이 중시되는 더 좋은 세상을 만들어 나가기 위해 헌신의 노력을 다 할 것입니다.
본 정보는 개인 구직자들의 취업지원을 위해 외국기업취업전문사이트 피플앤잡에서 수집한 정보이며, 채용회사의 사정에 따라 변경될 수 있습니다.
본 정보는 피플앤잡의 동의 및 허락 없이는 재배포 할 수 없습니다.
