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About 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.

Associate or Senior Associate, CMC RA

Tokyo, Tokyo, Japan Req ID 2206036 Category Regulatory Affairs Division AbbVie

Summary of Job Description:
Deliver the qualified drug timely to the patients by the contributing the regulatory approval of the
new drug as the CMC responsibility person and updating the CMC variations of marketed products.


Major Responsibilities:
• Positive contributions to establishment of CMC regulatory strategies, plans and timelines, to
ensure successful new registrations and effective product maintenances, in line with local
business objectives.
• Manage regulatory submissions process, prepare high quality submission packages and
responses to deficiency questions within applicable timelines.
• Work closely and swiftly with cross-functional and brand teams to update regulatory
projects, address critical issues and potential solutions.
• Building a good relationship with health authorities
• Monitor and forecast regulatory environment periodically, and assess impact to AbbVie
business.
• Grasping recent CMC regulatory trend by for example, networking with CMC regulatory
representatives from other companies
• Develop and maintain regulatory operation processes and systems to support regulatory
submissions and approvals in the most efficient.
• Develop and manage product registration database to ensure information transmission
timely and accurately.
• Review labeling, promotional and educational materials to ensure compliance.


Essential Skills & Abilities:
• Ability and desire to create results
• Requires excellent written and verbal communications in Japanese and business level
communications in English
• Ability to effectively work under tight deadlines and manage projects independently.
• Resourcefulness in solving problems
• Excellent people skills and an upbeat and enthusiastic attitude.


Education / Experience Required:
• Bachelor's degree or above in pharmacy or related science. Master degree is preferred.
• More than 3 years regulatory affairs experience in pharmaceutical or biotech industry.
• Knowledge and experience on CMC related regulations (incl. new chemical entities (NCE),
biologics).

Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

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