서울에서 최고의 (seoul) quality management 채용공고 20개(지금 채용 중!)

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

Major accountabilities

Review pipeline and set the registration strategy in collaboration with global RA and related CPO functions with support from senior specialist and manager
Achieve the best product registration with optimal label by conducting research on submission requirements and approval lead time in accordance with registration plan.
Support launches (artwork, barcode, Drug ID mark, etc.)

Perform CTA and get approval to ensure study timeline in collaboration with other CPO functions.
Support IMP management through confirmation of variant number.
Maintain product license by managing variations for label, quality (CMC and mfg. site) and administrative changes according to local law/regulation/guidelines, company strategy and global compliance.
Secure product license by managing Reevaluation/Renewal/Reexamination /HA safety communication
Ensure post approval activities (website, artwork, etc.)
Submit RMP by supporting of other function in line with global direction.
Be accountable for correct and timely update of RA compliance (registration) database (DRAGON)
Ensure industry compliance with NP4, KRPIA code of conduct
Support cross functional activities by delivering regulatory input
Understand basic knowledge on the legal frameworks, internal processes, GxP’s
Keep abreast of relevant laws /regulations and apply to related CPO activities
Ensure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all Novartis products according to respective SOP
Foster and maintain good relations with internal and external stakeholders.
Communicate effectively with HA and other BFs
Understand RA internal working process and handle own task well

Essential Requirements

Education: 4-year university degree, preferably in Pharmacy, Biochemistry, Chemistry, Life Sciences, or a related field
Languages: Fluent in both written and spoken English
Experience: Pharmaceutical industry experience preferred
Knowledge: Basic understanding of regulatory affairs, drug development process, and applicable pharmaceutical regulations/guidelines preferred

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

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

Division

Development

Business Unit

Development

Location

South Korea

Site

Seoul

Company / Legal Entity

KR01 (FCRS = KR001) Novartis Korea Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Temporary (Fixed Term)

Shift Work

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.

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