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RA Specialist, 전문의약품 인허가 (2년 계약직)
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
- Achieve the regulatory approval timely through the best registration strategy, and maintain product license with local regulation and global compliance standard, collaboration with local, global cross functions
- Maintain and secure product license in terms of CMC/CDS/etc. according to local regulations/law/guidelines, company strategy and global compliance
- Full compliance for RA system update, packing materials(artwork), promotional materials/activities, drug safety reporting etc
- Achieve new product registration in collaboration with Global team and related local functions (BU, Medical, QA, MA, etc.) to get the best product registration with commercially attractive labelling in accordance with registration plan
- Ensures the product registration application for new marketing authorization, variations such as production site transfer, new indications, etc. are submitted in a timely manner in compliance with internal and external regulatory requirements.
- Monitors the strategic issues that make changes to legislative requirements.
- Monitors the progress of audit and training on management of government licenses. e.g. Importation of pharmaceutical product, wholesaling and importation of medical device
- Ensure the readiness of packaging material reflecting product approval/variation and regulations
- Foster and maintain good relations with internal and external stakeholders
- Support new product registration in collaboration with Global RA and related local functions ( Marketing, Market Access, Medical, etc.) to achieve the best product registration with commercially attractive labelling in accordance with registration plan
- Ensure compliance with promotional material review, KRPIA code of conduct, relevant regulations and laws for related local activities (system update, packing materials, promotional materials/activities, drug safety reporting etc.)
Who You Are
- Bachelor’s Degree in related field
- 1+ years experience of pharmaceutical regulatory experience
- Fluent in Korean, Proficient in English
- Experience in multi-national Pharma company preferred
- Pharmacist license is a plus
- Good organizational skills and strong verbal and written communications.
•여러분이 찾고 계시는 채용 포지션이 없으신가요? 그렇다면 인재풀(클릭)에 여러분의 이력서를 등록해주세요! 향후 인력 수요가 있을 경우 최우선으로 안내드리겠습니다”
•지원 순으로 전형이 진행되며, 적합한 후보자 발견 시 채용이 바로 마감되오니 지원의사가 있으신 분들은 빠른 지원 바랍니다.
•서버 안정성을 위해, 인터넷 익스플로러가 아닌 구글크롬, 혹은 마이크로소프트 엣지를 통한 지원 바랍니다.
•보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.
•지원서의 기재사항이 사실과 다른 것으로 확인되거나 Reference from previous employer 상에 채용상의 결격사유가 확인될 경우 합격 또는 채용이 취소될 수 있습니다
•(The company reserves the right to withdraw the offer, it if discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application. The offer is conditional upon satisfactory results of reference checks.)
•머크와 카카오톡 친구를 맺어 최신 채용 소식을 받아보세요! (상위 QR코드 클릭 혹은 링크 클릭: http://pf.kakao.com/_wWuUb)
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
If you are a resident of Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html