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About the Role

The Regulatory Manager is responsible for developing and executing regulatory strategies for new product development, including OTC drugs, quasi-drugs, Foods with Functional Claims (FFC), and cosmetics. This role collaborates with global teams, internal stakeholders, and external partners to drive business growth and improve regulatory operations.

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, including consultations, submissions, and responses to inquiries.
• Prepare and review regulatory documents, such as consultation materials, application dossiers, and inquiry responses.
• Collaborate with cross-functional teams 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.

Requirements

• 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.
• 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.

Skills

• Regulatory Strategy
• Product Development
• Life Cycle Management
• Advertising Review
• Promotional Content Review
• Labeling Compliance
• Health Authority Interaction
• Regulatory Submissions
• Cross-functional Collaboration
• Global Team Collaboration
• Regulatory Intelligence
• Risk Assessment
• Stakeholder Relationship Management
• Team Leadership
• Project Management
• Japanese Regulatory Frameworks
• Japanese Language Proficiency
• English Language Proficiency

Location

• Japan

Work Type

• Full-time

Experience Level

• Minimum 5 years of experience in Regulatory Affairs
• Proven experience in team leadership or project leadership

Education Level

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

About the Company

• Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
• Our mission is to bring health in people’s hands by making self-care as simple as it should be.
• We serve half a billion consumers worldwide.
• We have 100 loved brands, an 11,000-strong global team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers.
• Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
• B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet.
• Find out more about our mission at www.opella.com.