会社概要

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.

求人内容

Summary of Job Description:

TA:Oncology

The Regulatory Affairs Manager will be responsible for ensuring first time approval of new products and new indications for existing products through participation in local brand teams as well as educating to his or her staffs.

Major Responsibilities:

• Develop local regulatory strategies and plan for major submissions to register New Chemical Entities (NCE) or new indications with Director of Regulatory Affairs and agree local submission timelines
• Lead the strategic discussion to accelerate development for Roadrunner projects. Based on the strategy we developed, negotiate with the regulatory authorities, and prepare for the early submission.
• Lead new product labeling development to archive target product profile and post marketing appropriate use of the product. Maintain and revise current labeling timely and appropriately in accordance with Global Company Core Data Sheet comply with regulatory requirements including GVP.
• Ensure Japan submission requirements are communicated to relevant regional and global regulatory team
• Determine local Regulatory Risk for submissions and risk mitigation strategies where relevant
• Inform group manager of Regulatory Affairs and New Product Information (NPI) team of progress of applications and issues impacting local applications
• Assist with major submissions to register NCEs or new indications for existing products when needed
• Maintaining regulatory records for assigned product portfolio in compliance with local and global procedures
• Manage interactions with PMDA and MHLW and maintain a productive working relationship
• Participate in / coordinate special project assignments as determined by the Director of Regulatory Affairs
• Support to the commercialization of products through participation in local NPI brand teams
• Educate and train regulatory strategy to the staffs

資格

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 in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical related fields is required
  • More than 5 years related experience in regulatory affairs, including regulatory strategy and regulatory maintenance, from CTN submission to approval of the compounds. .
  • Must have pharmaceutical experience

その他の情報

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​​

• This job is eligible to participate in our short-term incentive programs. ​​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVieは、誠実な事業運営、イノベーション推進、人々の生活の変革、地域社会への貢献、そしてダイバーシティ＆インクルージョンの促進などに尽力しています。AbbVieの採用方針は、人種や肌の色、宗教、国籍、年齢、性別（妊娠を含む）、身体的・精神的障がい、病気、遺伝情報、性同一性または表現、性的指向、婚姻状況、退役軍人やその他法的に保護されたグループに属するかどうか等に関わらず、高い能力を持つ優秀人財を従業員や候補者として差別することなく雇用することです。