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薬事戦略およびラベリングの統括を担う。
Take lead in RA activities to obtain new product approval. Manage partial change application.
This leadership position directs the regulatory development department, ensuring successful drug approvals. You will oversee regulatory compliance and collaborate with global teams to guide the development process while managing regulatory strategy for various therapeutic areas.
Be part of one of the top global biopharma companies in the industry. Take lead in post-marketing RA activities for the business.
Be part of one of the top global regulatory consulting companies in the industry. Take lead in applications and submissions for eCTD.
Be part of one of the top global biopharma companies in the industry. Take lead in RA activities to ensure effective product approval.
Take lead in RA development strategy to obtain product approval. Work with the RA head to ensure PMDA submission of J-NDAs are aligned.
Be part of one of the top global regulatory consulting companies in the industry. Take lead in applications for compliance inspections to obtain licensing.
Take lead in medical device RA activities for client needs on various projects. Act as a key consultant for class I-IV products for local regulations.
Take lead in CMC RA activities for client needs on various projects. Lead the CMC RA Team.
Be part of one of the top global rare disease company in the industry. Take lead in regulatory strategy/development to obtain product approval
Be part of one of the top life science businesses in the industry. Take lead in RA activities for the business to obtain product approval.
Be part of one of the top global pharma companies in the industry. Take lead in new drug application submission to obtain regulatory approval.
Be part of one of the top medical device companies in the industry. Take lead in RA activities for class I-IV products for approval and maintenance.
Take lead in the company starting up for their market entry to Japan. Take lead in the overall RA activities to obtain regulatory approval.
Take lead in regulatory activities for the business to ensure company products are align with local regulations. Making sure all data are correct such as labeling, packaging, artwork etc.
Be part of a top global pharmaceutical company in the industry. Take lead in CMC RA and QA activities as well as serving as the Hinseki.
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