RA Specialist
1개월전에
PRIMARY FUNCTION/OBJECTIVE
• To manage with the preparation of regulatory submissions of company products in order to obtain regulatory product licenses.
• To provide regulatory input on regulatory matters to company personnel.
CORE JOB RESPONSIBILITIES
• Manage registration of newline 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.
• Maintain contact with governmental officials of Korea MFDS on the application.
• 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 3 years of experience in regulatory affairs.
Additional Information
AbbVie 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.
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