Manager, Regulatory Affairs Specialty Care/GenMed

Responsible for leading the team and encouraging changes and challenges, influencing stakeholders inside and outside the company, contributing to the achievement of organizational goals, enhancing performance and productivity, and fostering talent development regardless of whether there are direct reports.

• Develop regulatory strategy for new drug developments, Health Authority meetings and Japan New Drug Submission (J-NDA) and provide regulatory expertise within project/product teams for products under development and/or marketed products (scope: new drug application, partial change application for new indication and/or new dosage and administration with clinical trial, new formulation regardless of clinical trial),

• Prepare Japanese Common Technical Documents (J-CTD) for the regulatory submission and arrange the internal review of J-CTD,

• Lead the preparation of Clinical Trial Notification (CTN), Health Authority meetings (e.g. PMDA Consultation Meetings) and major regulatory submission (e.g. J-NDA and J-sNDA) and/or any type of responses document to Health Authority questions with the stakeholders (Non- clinical, clinical, Medical, Pharmacovigilance, CMC etc.),

• Ensure maintenance and compliance of regulatory activities for development and marketed products,

• Accountable for defining the project strategy and associated timeline, identify the risk and mitigation as the JAPC representative on GRT.

• Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.

• Lead Japanese Package Insert Revision activities on Commercial and Medical Division’s request that is covered by PMDA New Drug Review Division.

Knowledge, Skills & Competencies / Language

• Knowledge of new drug development and regulatory review for the approval

• Ability to think logically

• Negotiation skills

• Communication skills

• Able to make continuous efforts with a focus on results

• A person who can work positively on his/her own.

• A person who can cooperate effectively with others

・Native level of Japanese, TOEIC 800 score or above in English.

Required English skills such as the ability to accurately understand and use technical terms related to drug development and regulations, create the specialized regulatory documents, advanced listening and speaking skills to effectively communicate in international meetings, expressing opinions, negotiations and discussions with Global stakeholders about the complicated issues, reading comprehension to efficiently read and understand English professional documents.

Qualifications

• Knowledge of regulatory, CMC, non-clinical, clinical development, and CTD

Description at the time of external employment

• At least 2 years for Regulatory and at least 5 years for R&D and/or Regulatory field in a pharmaceutical company or equivalent.