Regulatory Manager

Basic Function

The Regulatory Manager plays a critical role in developing and executing regulatory strategies for new product development, including OTC drugs, quasi-drugs, Foods with Functional Claims (FFC) and cosmetics. The position works closely with global teams, internal stakeholders, and external partners to contribute to business growth and enhance the quality of regulatory operations.

Scope of Responsibilities

● Develop and execute regulatory strategies for new product development, including Rx-to-OTC switches and product innovations.

● Lead regulatory activities for life cycle management of assigned products.

● Review and approve advertising materials, promotional content, and labeling to ensure regulatory compliance and appropriate claims.

● Lead negotiations and interactions with health authorities (such as the Ministry of Health, Labour and Welfare, PMDA, local government pharmaceutical divisions, and the Consumer Affairs Agency), including consultations, submissions, and responses to inquiries.

● Prepare and review regulatory documents (such as consultation materials, application dossiers, and inquiry responses) to ensure accuracy and compliance.

● Collaborate with cross-functional teams (Marketing, R&D, etc.) and global teams to ensure strategic alignment and smooth execution.

● Collect, analyze, and share regulatory intelligence; assess business impact and risks.

● Build and maintain strong relationships with external stakeholders, including trade associations and regulatory authorities.

● Provide guidance and coaching to Regulatory Specialists to enhance team capability.

● Actively participate in internal planning initiatives and cross-functional projects to support business objectives.

Knowledge, Skills and Abilities

● In-depth understanding of Japanese regulatory frameworks (Pharmaceuticals and Medical Devices Act, labeling regulations, FFC-related regulations).

● Experience in health authority interactions and regulatory submissions.

● Strong communication, negotiation, and coordination skills.

● Ability to collaborate effectively with global teams and external stakeholders.

● Project management skills.

● Native-level Japanese proficiency (written and spoken).

● Business-level English proficiency (written and spoken) is preferred; however, candidates with strong practical experience and expertise will be considered with flexibility on English requirements.

Education / Experience

● Bachelor's degree or higher in Pharmacy, Science, Agriculture, Life Sciences, or related fields.

● Minimum 5 years of experience in Regulatory Affairs (experience in OTC drugs and quasi-drugs preferred).

● Proven experience in team leadership or project leadership within regulatory functions.

● Experience working with global teams is a plus.

Industry-related activity experience preferred.