area representative 관련 취업정보
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Job Post Details
Regulatory Affairs Specialist/Sr.Regulatory Affairs Specialist - job post
채용 상세 정보
채용공고 세부 정보와 귀하의 프로필이 부합하는 점은 다음과 같습니다.채용공고 유형
- 정규직
지역
상세 직무 내용
Summary
- Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.
About the Role
Key Responsibilities:
- Achieve the best product registration with commercially attractive labelling in accordance
- with registration plan
- Maintain and secure product license in terms of CMC/CDS/safety update according to local
- regulations/law/guidelines, company strategy and global compliance
- Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for
- related CPO activities (DRAGON update, RMP, packing materials, promotional
- materials/activities, PMS/drug safety reporting etc.)
- Foster and maintain good relations with internal and external stakeholders.Reporting of technical complaints / adverse events / special case scenarios related to
- Novartis products within 24 hours of receipt. Distribution of marketing samples (where applicable)
Essential Requirements:
- For Specialist level - Preferably 1-2 years of experience in the pharmaceutical industry in a relevant field such as regulatory affairs, registration, or a directly related area.
- For Senior Specialist - Preferably 3-4 years of experience in the pharmaceutical industry in a relevant field such as regulatory affairs, registration, or a directly related area.
- Korea pharmacist license is preferred
- Languages: Good command in English (speaking and writing)
- Good Interpersonal skills
- Strong Project Management. Ability to work under pressure.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.