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 Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
求人内容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.
Develop regulatory strategies, plans and timelines, to ensure successful new registrations and effective product maintenance, in line with local business objectives.
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 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.
資格
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.
その他の情報
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。
Show more Show less
-
Tokyo - Midtown Tower GenmabGenmab is a biotechnology company that aims to improve patients' lives through innovative antibody medicines. · ...
-
Tokyo - Midtown Tower GenmabJenmaab is a global biotechnology company that aims to improve patients' lives through innovative antibody drugs. · ...
-
CMC RA Manager
2ヶ月前
Minato AbbVie ￥2,500,000 - ￥5,000,000 per yearDeliver qualified drugs timely to patients by contributing to regulatory approval of new drugs as CMC responsibility person. · ...
-
Tokyo, Tokyo GenmabJob summary · Genmab aims to improve patients' lives by developing innovative antibody drugs. · ResponsibilitiesMake a strategic J-NDA plan for RA CMC and execute. · Evaluate global CTD and conduct gap analysis. · ...
-
CMC-RA manager
3週間前
Tokyo Servier+ 10 years' practical experience with CMC-related roles preferred (CMC regulatory affairs, Analytical/Quality testing, or Manufacturing) in Pharma Industry Advanced degree in medical, pharmaceutical or life-science etc Hard skills/ Expertise: Idealy + 10 years' practical experien ...
-
RA Manager
2ヶ月前
Tokyo Barrington James ￥5,000,000 - ￥10,000,000 per yearRAマネージャーです。グローバル企業で感染症や体外診断領域に従事することができます。コロナやインフルエンザの検査キットでマーケットシェアが2位です。 · ...
-
RA Manager
4週間前
Tokyo Barrington James· 新薬・後発品(ジェネリック)の導入・維持管理を薬事の立場から担当 · 日本を含むグローバルのプロジェクトチームと連携し、薬事戦略の立案・進行管理を行う · ...
-
RA Associate Manager
2ヶ月前
Shinjuku Barrington James ￥50,000 - ￥70,000 per yearRA Associate Manager · ２０１３: · １ · ％.４ · ...
-
RA Associate Manager
2ヶ月前
Shinjuku-ku, Tokyo Barrington James ￥5,000,000 - ￥8,000,000 per year+校らGeneral · +３４ · ...
-
Manager, GRA CMC
2週間前
Tokyo, Tokyo SanofiThe incumbent regulatory professional is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices Japan. · ...
-
Tokyo Ipsen ￥4,000,000 - ￥12,000,000 per yearTo coordinate the CMC regulatory strategy activities for the assigned projects throughout the different phases of development from early clinical trials to initial marketing applications, · and life cycle management in Japan. · ...
-
Japan BeiGene+BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. · +Local Representative for Regulatory Affairs Local Compliance · Provide leadership and strategic direction for Regu ...
-
Tokyo, Tokyo PERSOL CAREER BRS (Bilingual Recruitment Solutions)We are a leading Global CRO Company providing drug discovery development lifecycle management and laboratory services. · We provide tailored solutions to ensure safety efficacy of clients' needs focused on compliance with strict regulations. · Clinical Trial Monitoring for Phase ...
-
Tokyo myGwork - LGBTQ+ Business CommunityThe MAS role family comprises a variety of medical scientific specialties. · This job is with Pfizer, · a member of myGwork –
-
Tokyo CSLThe Regulatory CMC Expert evaluates all CMC regulatory aspects related to the assigned products (including both development products and established products) in Japan. · The Regulatory CMC Expert develops and executes CMC strategies for development products/life-cycle management ...
-
Tokyo Rockwell Automation ￥80,000 - ￥150,000 per yearThe Technical Account Manager is responsible for managing customer relationships with assigned accounts at Rockwell Automation/Plex. · Provide a single contact for customer engagement and escalation. · Establish working relationships with assigned customer accounts. · Rapidly add ...
-
Tokyo Merck HealthcareThe Regulatory Affairs Senior Manager focuses on some of the following activities in Regulatory Affairs Group. This includes leading RA-related Health Authority interactions, preparing Japan NDA activities and HA's review for approval, and managing outsourcing vendors as needed. ...
-
Relationship Analyst
2週間前
Tokyo Wellington ManagementThe Client Group in Tokyo has an opening for a Relationship Analyst The successful candidate will be an integral member of our Tokyo team and will be primarily responsible for supporting and strengthening our relationships with institutional clients. · Commanding a thorough knowl ...
-
Relationship Analyst
2週間前
Tokyo Wellington ManagementThe Client Group in Tokyo has an opening for a Relationship Analyst ("RA"). The successful candidate will be an integral member of our Tokyo team and will be primarily responsible for supporting and strengthening our relationships with institutional clients. · Commanding a thorou ...
-
Tokyo SERVIER MONDE Full timeServier is committed to therapeutic progress for patients benefit. · Work within Servier Group helps advance therapeutic progress. · ...
-
Tokyo Specialized GroupA global pharmaceutical organization is seeking a Japan Portfolio Project Lead to act as the end-to-end owner of development pipelines in Japan, from early development through approval and launch. · ...
