RA Manager

«out AbbVie AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. PRIMARY OBJECTIVE: To manage 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: Develop registration strategies and implement regulatory plan in accordance with strategic company objectives. 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 Prepare safety update reports, certified product details and import permits Maintain contact with governmental officials of Korea MFDS to facilitate evaluation processes. Liaise with operations department and others to maintain product changes and ensure these comply with regulations. Review labeling, product information and promotional materials for compliance with relevant regulations and codes. Provide support for marketing plans and launch teams Maintain good knowledge of the relevant Regulations & Code. Bridge for translating regulatory strategies and goals into launch plans that drive the business Manage performance of their Therapeutic Area Coach and develop team members to achieve their best target Shape the culture of the team Be developed their qualification as a successor of RA director Back-up role of RA director (in the absence of RA Director) Qualifications EDUCATION/QUALIFICATIONS/EXPERIENCE: University degree in appropriate discipline More than 7 year experience in a regulatory position in industry Must be proficient in both spoken and written English. *애브비는 개인정보 보호법과 채용 절차의 공정화에 관한 법률를 준수합니다. 보내주신 이력서는 채용하는 포지션에 대한 채용 검토 목적으로만 사용되며 사용 목적이 다한 즉시 폐기합니다. Travel Yes, 10 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.