Regulatory Project / Products

R&D Regulatory Affairs

The R&D Regulatory Affairs has responsibility for managing products under development and/or marketed products with new indications.

• 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,

• 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

Qualifications

Description at the time of external employment: At least 2 years for R&D or Regulatory field in a pharmaceutical company or equivalent.

Selling points

In regulatory affairs, as a regulatory expert, we participate in pharmaceutical project teams to provide advice and support to the team. Through this work, we can learn about regulatory changes and the evolution of the development environment related to drug development, thereby enhancing my expertise.

The essence and appeal of regulatory affairs work lies in engaging in constructive discussions with health authorities regarding drug development plans formulated by project teams, bringing these plans to fruition, and delivering medicines to patients as quickly as possible.