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Take lead in regulatory operations and GxP documentation activities for company clients. Deliver effective and high quality solutions.
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.
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.
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.
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.
薬事業務
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.
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