[제약] RA Specialist (의약품 인허가)

Posté 21 juil. 2022

Seoul, Seoul - Korea, Republic of

Demander un identifiant 253103

Détails

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

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.

 


Your Role

 

  • 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
  • 3+ years experience of pharmaceutical regulatory experience
  • Fluent in Korean, Proficient in English
  • Pharmaceutical license is a plus
  • Good organizational skills and strong verbal and written communications.

 

 


• 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.)


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. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

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