CH RA Associate (육아휴직대체 20개월 계약직)

[Your Tasks and Responsibilities]

1) Ensure proper maintenance and update of product licenses in compliance with global standard and local regulations.

2) Ensure the regulatory compliance for a life-cycle management: Labelling/CMC changes, Dossier gap analysis etc.

3) Review and prepare the application document files for MAA, variations, pre-evaluations, notifications, reports etc. to health authorities. 

4) Able to manage the assigned projects by providing the regulatory experts

5) Review the texts on packaging materials to ensure compliance with registration and legal requirements. Approve the packaging artworks if necessary.

6) Record the tracking data of local actions in a timely manner into the global regulatory databases. Maintain the product archiving of assigned portfolio in accordance to global/local SOP or OI : Documentation approvals, filing correspondences and local dossier archive etc.

7) Liaise with 3rd parties/distributors/agencies for contract management in relation to registration activities if needed.

8) Provide the local RA intelligence: Identify current and emerging national regulations which impact the product development and/or marketing processes and ensures appropriate the contribution and communication.

[Qualifications / Requirement]

- At least 1 year of experiences in regulatory affairs of Chemical or Biologic drug/ Medical devices/ Quasi-drug/ Cosmetics/ Health functional supplement food in pharmaceutical industry.

- Bachelor or Master's degree in Life Science, Biotechnology, Natural science, Pharmacy or Medicine etc.

- Ability to work by communicating effectively in orally and reading/writing via email correspondence and TC call meetings.

- Ability to focus on multiple issues at a time. Ability to organize and prioritize the diverse activities in changing situation and often under time pressure.