Summary of Job Description:

Deliver the qualified drug timely to the patients by contributing to the regulatory approval of the new drug as the CMC responsibility person and updating regulatory commitments of the marketed products according to CMC variations.

Major Responsibilities:

• Develop regulatory strategies, plans and timelines, to ensure successful new registrations and effective product maintenance, 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.
• Liaise with drug authorities for insights into current activities and future direction of regulation.
• Monitor and forecast regulatory environment periodically, and assess impact to Abb Vie 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.

Essential Skills & Abilities:

• 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.
• Ability and desire to create results.
• Excellent people skills and an upbeat and enthusiastic attitude.

Education / Experience Required:

• Bachelor's degree or above in pharmacy or related science. Master’s degree is preferred.
• More than 5 years of regulatory affairs related experience in pharmaceutical or biotech industry.
• Knowledge and experience of CMC related regulations (incl. new chemical entities (NCE), biologics).
• Working experience with multinational companies is preferred.

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。

Abb Vie'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 Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.