head of regulatory affairs.

■ About the CompanyOur client is the Japan subsidiary of a global healthcare company that aims to improve health and enhance the quality of medical care through innovative pharmaceutical and nutrition products. The company is committed to innovation and sustainable growth, with a corporate culture that emphasizes cutting-edge scientific solutions and a focus on continuous improvement.■ Summary of the PositionIn this role, you will oversee all regulatory activities related to pharmaceuticals and nutrition products, ensuring compliance with marketing authorization requirements and maintaining product approvals. You will lead the regulatory strategy for nutrition products, drive key projects, and liaise with regulatory authorities. Additionally, you will manage quality and safety operations in line with Japan's regulatory standards, ensuring the successful commercialization and life-cycle management of the company’s products.■ Key Responsibilities:・Lead regulatory operations for both pharmaceuticals and nutrition products・Manage product registration and life-cycle activities for new and existing products・Coordinate with regulatory agencies and prepare required documentation・Monitor regulatory trends and integrate findings into product strategy・Collaborate with cross-functional teams to maintain quality and compliance standards

求められる経験
■ Education
・BS in pharmacy, biology, chemistry, pharmacology, or related subject is required. Advanced degree, MS or Ph.D. is preferred.

■ Background
・Pharmacist License is REQUIRED.
・7-10 years’ experience in Japan pharmaceutical regulatory environment.
・Experience within food regulatory area is highly preferred, in addition to pharmaceutical experience.
・Working knowledge of Japan Food law
・Communication with non-Japanese through English conversation required.
・Worked with commercial teams or has similar experience beyond core regulatory experience, demonstrating comfort level interacting with commercial / manufacturing functions.
・Familiar with regulatory requirements on quality (GMP, GQP, CMC)

■ Required Functional Competencies
Leadership Competencies
1. Set vision and strategy.
2. Anticipate.
3. Innovate.
4. Build.
5. Deliver Results.

■ Knowledge, Skills and Functional Competencies
1. Pharmaceutical regulations for marketed products in safety and quality
2. Food regulations for New Functional Claim regulation, FOSHU, FFS products for registration and ongoing management
3. GMP regulations
4. Current manufacturing alliance and regulatory roles
5. GVP regulations

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日
-

給与
年収1,600 ～ 2,500万円

賞与
-
雇用期間
期間の定めなし