Primary Function    

1. Marketing Supervisor General of Marketing Authorization Holder (MAH) as per The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical devices, Regenerative and Cellular Therapy Products, and Cosmetics. (PMD Act)

2. Responsibility for all regulatory affairs matters for ANI marketed products in Japan, obtaining and maintaining approval within relevant regulations, including the following:

• Manage MAH for Drug Nutrition by leading Quality Manager and Safety Manger per regulation requirements

• Preparing high quality drug application materials for minor change notification, partial change application and new drug registrations.

• Set the regulatory strategy for food categorized product, identifying opportunities in both the FSMP and general food space.

• Ensure accurate and timely pharmacovigilance reporting with support from medical affairs department.

• Coordinate external engagement activities with regulatory agencies, including the preparation of required documents

• Interface with appropriate regulatory agencies, ANRA, JPMA and other pharmaceutical and nutrition industries’ associations.

• Oversee marketing activities and make necessary measures to comply with the relevant promotion codes and regulations.

• Contribute actively to commercial strategy for existing products and new foods via active monitoring of emerging regulations and trends.

• Identify and drive projects that support nutrition business via regulatory assessment

Core Job 

Under guidance/supervision of upper management:

• Responsible for oversight of all regulatory subjects for Abbott Nutrition marketed products

• Mentor to other departments’ activities for regulatory and medical topics –providing answers directly or leading the group to proper medical resources in Abbott

• Maintain marketing authorization of products through change application and life cycle management activities

• Build organization through succession planning and individual growth plans for managers to develop next generation managers in all key marketing areas/functions.

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