- Execute local preclinical documentation (Investigators Brochure for J-CTN, Briefing Document for PMDA consultation, and CTD preparation for J-NDA) and RTQs from Japan Health Authorities with Global Translational Science and Preclinical Development and manage outside service providers
- Bring local preclinical expertise to Japan Project Teams and Global Product Strategic Teams in Amgen Key Activities
- Ensure quality of contents and of Japanese translation of preclinical parts in CTD for J-NDA and IB for J-CTN
- Input Japan-specific requirements for preclinical development to global members as a local expert
- Prepare and respond to preclinical questions for CTD and IB from PMDA with global members
- Interact with Japanese healthcare providers (PMDA, academic organizations, and National Institute of Health Science) to obtain acceptability of preclinical data for J-NDA of innovative medicines
- Interact with Key Opinion Leaders and/or Principle Investigators to convey preclinical knowledge of candidates (more of a focus area in Japan than in the west) Knowledge and Skills
- Knowledge of preclinical science (toxicology, pharmacology, and/or drug metabolism)
- Knowledge for documentation (preclinical writing) and the quality of IB and CTD
- Knowledge of Preclinical regulations/guidelines (including GLP and ICH) in Japan
- Preclinical (toxicology, pharmacology, and/or drug metabolism) experiences in research lab
- Working in matrix environments as One Team
- Communication skills
- Negotiation skills to Japan Health Authorities
- English conversation, read, and writing
Computers:
Microsoft Outlook/ Word/ Excel/Power Point Education & Experience (Basic) Master or Doctorate degree and 10 years of directly related experience Over total 5 years experiences with preclinical pharmacology, toxicology and/or drug metabolism for supporting CTN and NDA submission in Japan Over 5 years experiences in pharmaceutical industry Education & Experience (Preferred) Over 5 NDA submissions and approvals in Japan (more preferred biologic experience) .
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit and follow us on-
Japan - Tokyo 1112 Amgen K.K.Facilitate patient access to Amgen products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise; interfacing with agencies on regulators; aligning with key cross-functional partners; integrating into Amgen's commercialization ...
-
Tokyo Amgen Full time+Execute local preclinical documentation and manage outside service providers.+Bring local preclinical expertise to Japan Project Teams and Global Product Strategic Teams in Amgen+Ensure quality of contents and of Japanese translation of preclinical parts in CTD for J-NDA and IB ...
-
Tokyo BD ￥100,000 - ￥200,000 per year+ · + · +h2+bJob summary/b/h2+pThe Senior Manager responsible for all aspects of regulatory affairs for BDB and DS./ppressible for all aspects of regulatory affairs for BDB and DS.+h2+bJob Description Summary/b/h2+pResponsible for all aspects of regulatory affairs +/pposition ove ...
-
Minato BD Nogales NorteBDは、ヘルスケア分野における多様なニーズに応える医療技術、デバイス、実験機器を開発する世界をリードする医療技術企業です。感染症の撲滅と治癒を目指す戦いにおいて最先端の研究を提供し国内外の人々に画期的な医療・バイオテクノロジーサービスへのアクセスを向上させるという私たちの使命で、私たちが求めています。 · ...
-
Minato-ku BD Full time￥1,584,000 - ￥2,442,000 per year薬事担当シニアマネージャーは、ライフサイエンス部門の薬事機能を統括し、バイオサイエンス事業部と診断ソリューション事業部の両方を統括します。体外診断用医薬品(IVD)関連規制を含む国内外の規制へのコンプライアンスを確保するための薬事戦略の策定と実行을担当します。 · ...
-
Tokyo BD ￥25,000,000 - ￥35,000,000 per year· BD 안세요 전속,Waters Corp.첟BD안세요 전속,Waters Corp. ...
-
Tokyo, Tokyo GE HealthCare ￥6,000,000 - ￥12,000,000 per yearWe are seeking a highly motivated Regulatory Affairs Manager to lead regulatory strategies and ensure compliance for pharmaceutical and medical device products. This role plays a critical part in supporting product launches, ...
-
Tokyo, Tokyo iNova Pharmaceuticals ￥4,500,000 - ￥8,000,000 per yearThe Company is seeking a Regulatory Affairs Manager to join its team on a full-time basis. The position is responsible for setting & executing the Japan regulatory strategy, managing product registration and maintenance, local regulatory support for the new product launch and loc ...
-
Tokyo Dow ￥1,500,000 - ￥2,800,000 per yearDow believes in putting people first and delivering integrity respect and safety to customers employees and the planet Our purpose is simple -to deliver a sustainable future for the world through science collaboration If you're looking for a challenge meaningful role you're in th ...
-
Greater Tokyo Area Kingfisher HR Solutions GroupThis position offers a unique opportunity for growth with an international cosmetics manufacturer expanding into Japan. · The role involves managing compliance systems for pharmaceuticals , quasi-drugs ,and cosmetics . · ...
-
Tokyo IFFAre you passionate about advancing health and wellness through innovative bioscience solutions? IFF is a global leader in flavors, fragrances, food ingredients and health & biosciences. We deliver sustainable innovations that elevate everyday products. · ...
-
Tokyo, Tokyo Merck Healthcare ￥5,000,000 - ￥10,000,000 per yearThe Regulatory Affairs Senior Manager focuses on regulatory activities from development to life cycle management with global and Japan stakeholders. · Lead RA-related Health Authority (HA) interactions. · Lead New Drug Application (NDA) · ...
-
Tokyo-To, Japan JPMorganChaseJoin a team where your expertise and ideas drive accuracy and innovation in regulatory reporting. · ...
-
Tokyo MedpaceWe are seeking a full-time Regulatory Submissions Manager to join our Site Activation & Maintenance team in Tokyo, Japan. This position plays a key role in the clinical trial management process at Medpace. · Efficiently manage and successfully execute all aspects of global projec ...
-
Tokyo Medpace, Inc. Full time+Job summary · We are currently seeking a full-time Regulatory Submissions Manager to join our Site Activation & Maintenance team in Tokyo. · +Efficiently manage and successfully execute all aspects of global project start-up; · Perform quality checks on submission documents and ...
-
Japan Ceva Sante AnimaleWe are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife. Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, anim ...
-
Japan ColgateThe Regulatory Affairs Manager supports the Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development, manufacturing, distribution, marketing and sales of Hill's products in Japan. · ...
-
Japan - Tokyo AmgenThe Japan Regulatory Strategy Group Sr Mgr is developing and executing the regulatory strategies and plans; providing strategic regulatory expertise for drug development; interfacing with regulatory authorities; aligning with key cross-functional partners; integrating into Amgen' ...
-
Minato RegeneronWe are now looking for in-country regulatory professionals to join our growing global regulatory team.This is an exciting opportunity to demonstrate your knowledge in leading regulatory processes for biological products and regenerative medicines in Japan. · ...
-
Minato AbbVie ￥3,000,000 - ￥6,000,000 per yearThe Manager, Regulatory Submissions manages high impact, complex submission projects involving multiple cross-functional regulatory submission teams. · Independently manages high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ...
-
Tokyo Regeneron Pharmaceuticals Full time￥9,000,000 - ￥12,300,000 per yearWe are now looking for in-country regulatory professionals to join our growing global regulatory team. · ...
