※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
- Provide strategic Japanese and Asian regulatory leadership to project teams in early and late stage clinical development.
- Lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle from Japan and Asia regional perspective. This will include clinical trial applications, pediatric investigation plans, briefing documents and NDAs and/or MAAs.
- Identify potential regulatory risks to the strategic / operational plans and propose options to mitigate risks.
- Lead negotiations with Japanese and Asian Regulatory Agencies.
- Lead the delivery of timely Japan and Asia marketing approvals and advantageous product information in keeping with the needs identified by the business and in compliance with local market regulations.
- Define innovative strategies to partner with Japanese and Asian Regulatory Agencies to increase the predictability of regulatory outcome and to provide the regulatory platform to support market access.
- Manage relationships with CROs and Regulatory Affairs consultancies to ensure business objectives are met.
- Provide regulatory due diligence assessments in cooperation with Business Development as required.
- Contribute to the preparation of new regulatory guidance and communicate the impact of new regulatory requirements across the organization.
- Must be able and willing to work in a high-visibility, fast-paced environment. Must be flexible, detail-oriented, and possess good analytical and problem-solving skills.
- Has strong blend of being a team player, but also able to work on own initiative and prepared to take ownership and responsibility for his/her actions.
- Results focused and able to work under pressure and meet deadlines.
- Confident and has the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally.
- Adaptable and self-motivated, able to prioritize effectively with good problem-solving and planning abilities.
- Demonstrate clear alignment with Company's Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence.
- University Degree in Science or related discipline. A higher degree would be desirable.
- At least ten years of experience of working in one or more areas in Regulatory Affairs in the pharmaceutical or related industry, or experience at a health authority.
- Ideally a combined mix of large company best practices and smaller company adaptability and experience.
- Sound knowledge and experience of Regulatory Affairs and associated requirements, plus pharmaceutical industry experience of clinical trial and drug development work with a track record of successful drug development through product approval in Japan.
- Thorough knowledge of the drug development process.
- Experience in interfacing with Regulatory Authorities in Japan and an excellent track record of building relationships with and influencing Regulatory Agencies.
- Excellent written and verbal communication skills (in both Japanese and English).
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.