Job Information
AbbVie RA Specialist in Seoul, South Korea
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .
Job Description
PRIMARY OBJECTIVE:
To manage/assist with the preparation of regulatory submissions of company products in order to obtain necessary regulatory approvals
To provide regulatory input on regulatory matters to company personnel.
CORE JOB RESPONSIBILITIES:
Manage registration of new/line extension products, variations to marketed products to ensure regulatory approvals are achieved in accordance with Company objectives.
Coordinate responses to deficiency letters and other requests for data in agreed timelines
Liaise with operations department and others to maintain product changes and ensure these comply with regulations.
Maintaining contact with governmental officials of MFDS on the application by themselves for their projects
Cross functional communication for regulatory activities of the products
Liaise with operations department and others to maintain product changes and ensure these comply with regulations.
Review labeling and product information for compliance with relevant regulations and codes.
Maintain good knowledge of the relevant Regulations & Code.
Qualifications
PREFERRED QUALIFICATIONS
University degree in appropriate discipline.
Minimum 1 year experiences in regulatory affairs.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html