Regulatory Project / Products

Role & Responsibilities

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.