Overseas RA Associate Director

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Job details

Company overview

Responsibilities

Regarding Company's Pharmaceutical products sold overseas, we are in compliance with Japanese and　overseas regulations regarding the products, manufacturing plants, and pharmaceutical ingredients. To understand the development and regulatory affairs of the project and to be able to carry out the development and regulatory affairs of the project. The following are examples of the duties of this position, but the specific tasks will be determined based on the individual's experience and aptitude.In order to obtain approval from overseas regulatory authorities for the pharmaceutical ingredients, formulations, and manufacturing sites used in products for overseas markets. Comply with overseas pharmaceutical regulations, collaborate with internal and external stakeholders, and develop and execute a pharmaceutical application strategy to obtain approval from the authorities (preparing various certificates, CTDs, and other application documents, and responding to inquiries).
Main responsibilities:

• Planning and execution of development strategies and plans for new products for overseas markets 
• Drug regulatory research, evaluation of subcontractors and conclusion of contracts, project promotion
• Acquisition of various certificates, preparation of application documents such as CTD, response to inquiries from regulatory authorities in each country, etc.
• Maintenance of approval for products already approved overseas, planning and execution of change management plans
• Promoting approval maintenance and change management in line with the latest regulations, and obtaining approval from authorities 

Requirements

Minimum requirements:

• Knowledge of pharmaceutical regulations for Japan and overseas
  • 3 years of experience in pharmaceutical or food development (either for Japan or overseas) 
• Communication with overseas partners
  • English : Business level [TOEIC Listening & Reading Test Level B (730 points or higher)]

Preferred qualifications:

• Experience in pharmaceutical development for overseas medical drugs, over-the-counter drugs, and food
• Experience dealing with overseas authorities 
• Knowledge and work experience related to CMC (Chemistry, Manufacturing and Control)
• Experience in regulatory affairs development in China 
• Leadership to coordinate business collaboration both inside and outside the company, both domestically and internationally
• Ability to collect and organize fact-based information, act independently, and take an overall optimal approach
• Having a strong will to comply with regulations

Salary

8 - 14 million yen

Location

Tokyo