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Let our industry specialists listen to your aspirations and present your story to the organisations in Japan that fit you the best as we collaborate to write the next chapter of your successful career.
Japan's leading employers trust us to deliver fast, efficient hiring solutions that are tailored to their exact requirements. Browse our range of bespoke services and resources
An international biopharmaceutical company is searching for a Regulatory Specialist. The successful candidate will have the chance to liaise with key opinion leaders, consultants, and regulatory authorities, ensuring effective communication and endorsement for development strategies. This is a full-remote position.
Responsibilities:
Maintain effective communication between management, clients, KOLs, and consultants regarding Japanese and Asian drug development strategies
Liaise with Japanese and other Asian regulatory authorities to gain endorsement for development strategies and conduct of specific clinical trials
Prepare, review, and finalise regulatory documents for approval by Project Director or other authorised staff
Coordinate timely submission of regulatory documents to regulatory authorities
Plan and execute consultations with regulatory authorities (PMDA, MHLW) and KOL meetings
Support the filing and defence of applications to enable the initiation of clinical trials in Japan and other Asian countries
Ensure the timely advancement of projects from the stage of regulatory strategy development through clinical trial implementation
Coordinate logistics for projects including vendor management and arrangement of internal/external meetings
Requirements:
Bachelor’s degree or above
Strong authoring and proofreading skills and searching skills
Ability to work flexibly and effectively both independently and as part of a team with clients, external consultants, regulators, and Ascent colleagues
Skilled in MS Office Suite (MS Project)
Proficient in Japanese and English
About the Company: This company is widely recognised for its expertise in global drug development. Headquartered in Asia, the organisation has brought valuable contribution to medical breakthroughs.
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