South Korea Job Openings

Novartis

Regulatory Affairs Specialist (1 Year Contract)

FULL TIME & CONTRACT

November 6, 2024

Summary

Internal Role Title: Regulatory Affairs Specialist

Location: Seoul, Korea #LI-Hybrid

This is a contract position of 1 year (1 Jan -31 Dec 2025).

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the Role:
The RA Specialist is to support the dossier preparation, submission and approval from MFDS for NTO related product registration and maintenance complying with Regulations and SOPs.

About the Role

Key Responsibilities:

Support to prepare dossiers for NTO related new products registration & approved products maintenance and support to obtain NTO related approvals from MFDS.
Support the NTO related CTA actions in collaboration with relevant Stake Holders (e.g., medical team, global team, CTA Hub etc.), if required.
Ensure NTO related Novartis compliance with P3, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, artwork, barcode, Drug ID mark, promotional materials/activities, PMS/drug safety reporting etc.).
Ensure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all Novartis products according to respective SOP
Any other NTO related RA activities, if needed

Essential Requirements:

3-4 years university degree preferably majored in chemistry, biology or pharmacy.
Preferably 1-2 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
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

Division

Development

Business Unit

Innovative Medicines

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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