開発薬事 / Regulatory Affairs, Associate Director

Company Overview
【事業拡大中】3年で三桁成長を遂げた希少疾患特化スペシャリティファーマ

Job Description
We are seeking a highly motivated, energetic professional capable of working effectively in fast-paced environment to join our International Regulatory Affairs team. This position will be responsible for developing the strategy, preparation and execution of regulatory submissions (marketing applications (MAs) and post-marketing maintenance) for our products, interfacing with the Japanese regulatory authorities (MHLW and/or PMDA), and for providing insight and support for clinical development in Japan. This position is based in the Tokyo office.

RESPONSIBILITIES
Develop Japanese Regulatory filing strategies and identify risks and potential gating factors. Play an active role in leading the strategic planning and preparation of complex submissions including but not limited to the following: JNDA/JsNDA (content development, assembly of the dossier, submission, through approval); post-marketing maintenance including re-examinations, ; JAN applications, expedited pathway applications and any other required submissions in Japan. Must ensure all submissions are prepared in accordance with JP regulations. Serve as primary liaison with the Regulatory authorities (e.g., MHLW and/or PMDA) and interface on behalf of our company to negotiate as needed to support plans for new drug registrations and activities for existing product licenses. Lead in preparation for and execution of Agency meetings.
Actively participate in multi-functional global team environment, and interface closely with U.S. and other global offices to align on operational and strategic deliverables.

Evaluate new and emerging regulations/guidance to advise the company on the Japanese Regulatory environment and changes that could impact our products or plans.

CONTACTS
The candidate must interact with Japan team members, International team members, and colleagues based in the global company headquarter in the US.
The position will report directly to the Head of APAC Regulatory Affairs based in Tokyo.

SUPERVISOR RESPONSIBILITY
No direct reports.

Requirements
EDUCATION
- State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
- A bachelor of science degree in a life science.
- Qualified Pharmacist is required.
- Fluent in Japanese and English.

EXPERIENCE
- Minimum of ten years of industry experience with at least eight years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the Japanese regulatory environment.
- Proven track record for preparing, submitting, and gaining approvals for JNDAs.
- The candidate is expected to have a thorough understanding of relevant drug development regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
- Proficiency with computer and standard software programs is required. Candidate must be fluent in English, both verbal and written (technical). Strong collaborative skills are needed as this position requires close working relationships with stakeholders both inside and outside of the company. Excellent verbal, written and presentation skills are also required.

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