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Be part of the regulatory strategy development for new/existing product approval. Provide expertise in effective regulatory stand point for market access for company's products.
Take lead in regulatory submission activities for the business to get product approval. Be involved in publishing and archiving activities to ensure best practices.
Be part of the RA department in leading regulatory submissions and approval for company's products in the Japan market. Lead in regulatory affairs strategies to align with global objectives.
Be part of a global renown biopharma with rich development pipeline. Take lead in CMC RA activities to obtain regulatory approval.
非臨床メディカルライターとして、薬事関連文書(CTD、コンサルテーション用ブリーフィング文書など)の非臨床部分を中心に専門性を発揮し、医薬品開発プロセス全体、およびJ-NDAの申請から承認までの戦略的な薬事関連の議論に積極的に関与する。
Lead in new product launch submissions to obtain regulatory approval for Japan. Align company strategies to align with local regulations.
Take lead in the RA department for new/existing applications/maintenance. Be part of the leadership team of the company.
Be part of the regulatory affairs development strategy to obtain product approval. Maintain good relationships with health authorities and align global objectives to local goals.
Take lead in CMC RA submissions and development strategy to obtain product approval. Prepare CMC documentations and management of post-approval CMC.
開発薬事として担当プロジェクトの臨床試験相移行や申請における薬事戦略の策定とGlobalへのinputと調整、日本の規制当局との折衝など、開発薬事関連業務全般をご担当いただきます。
Supporting drug development strategies, maintaining communication with regulatory authorities, preparing regulatory documents for approval, coordinating submissions, executing consultations with regulatory authorities and KOL meetings, as well as managing company's projects, coordinating logistics, and tracking project time lines, budgets, and staff utilisation. The position involves a combination of regulatory management and project management tasks.
Take lead in CMC RA activities to obtain/maintain regulatory approval. Be in charge of hands-on management of new products, line extension, and maintenance from a technical as well as operational point of view.
Lead in regulatory operation activities for eCTD submissions for new applications. Perform submissions and other submission preparation activities.
Be part of a leading global medical device company specialising in digestive and pain management products. Lead in RAQA activities as well as the department.
Take lead of the RA organisation to obtain new product approval as well as maintaining existing products. Act as a senior leader of the organisation to align regulatory strategies between global and local regulations.
As part of the global RA team, support in RA activities to obtain regulatory approval for companies products and post approval maintenance. Align company strategies to align with local regulations.
Be part of the RA department in leading regulatory submissions and approval for company's products in the Japan market. Manage post-approval activities to ensure products are aligned with local regulations.
Reporting to the sokatsu, take lead in RA (70%) and Safety (30%) activities as well as be the anseki. Support the product launch of new products, maintenance of existing products, and vigilance.
Take lead in CMC RA application work to obtain regulatory approval of new/existing products. In put Japanese CMC regulatory requirements based on global strategy.
Be a critical member of the business from an RAQA point of view. Take lead in registration of company's products for regulatory approval as well as maintaining effective compliance.
Take lead in RAQA activities for the business to obtain new product approval for the company. Take on sokatsu responsibilities as a licensed pharmacist and as the point of contact.
Reporting to the Director of JAPAC, lead in commercial RAQA functions to support the Japan business. Manage the team to achieve effective results.
Take lead in the obtainment of new product approval for medical device, pharmaceuticals, and quasi-drugs for the business. Maintain business license approval and regulatory review.
製品の薬事業務(詳細を面談時にお伝え致します)
Take lead in regulatory responsibilities to obtain/obtain new and existing product licenses. Create/revise labeling, artwork, and other requirements to ensure alignment with local regulations.
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