Senior Director Regulatory Affairs

Tokyo Permanent ¥18,000,000 - ¥26,000,000
  • Join the fast growing global Biotech known for mRNA therapeutics.
  • Build out RA group from the ground up in newly established Japan business.

About Our Client

  • Client is one of the hottest growing companies globally and looking to make a huge and immediate impact in Japan with their COVID-19 vaccine.
  • The company builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinical phase.

Job Description

  • Perform the role of Supervisor General and provide oversight to the QA Manager and Safety Manager.
  • Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including Japanese regulatory documents such as meeting requests,
    briefing books, orphan drug designations, DSURs, NDS, etc.
  • Work with Global Regulatory Sciences and the Global Regulatory Teams regarding the development
    and execution of regulatory strategy in Japan.
  • Identify and assess regulatory risks for assigned projects or programs.
  • Prepare and deliver effective communications and presentations for external and internal audiences.

The Successful Applicant

  • Degree in Pharmacy or Bachelor's degree or higher (preferably in a science or health related field)
  • 10+ years of experience in the Pharmaceutical industry. 7+ years of experience in Regulatory strategy
    and preferably had experience in the Supervisor General role.
  • Strong knowledge of current Japanese, EU, US, and International regulations related to the clinical, nonclinical, and CMC development.
  • Strong experience with CTD format and content regulatory filings.
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development,
    product registration, line extension and license maintenance in Japan.
  • Creates and maintains the Japanese-specific parts of regulatory dossiers including Information for
    Professionals and Patient and Packaging Information as well as National Succinct Statement.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive
    amendments or supplements.
  • Ability to work independently to manage multiple projects in a fast-paced environment.
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive
    meeting each program's critical regulatory milestones.
  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams
    and senior management, as relevant.
  • Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons
    learned. Fluency in Japanese and English are required.
  • A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and

What's on Offer

  • Equity package included.
  • Number of leadership teams.
Max Kuroiwa
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Max Kuroiwa
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