【Consumer】 Regulatory Affairs Associate Manager

【Consumer】Regulatory Affairs Associate Manager (Senior Specialist)

Division:  Regulatory Affairs, Johnson & Johnson K.K. Consumer Company

Position Title: Associate Manager

• Develop and flawlessly execute regulatory strategies to the Japan Consumer business.  This might include, but is not limited to new product development/introduction, life cycle management, due diligence, preparation of regulatory submissions to PMDA/Tokyo for registration of new products, ingredients, changes to marketed products;
• Help develop and approve innovative claims for products;
• Participate in key industry associations (JSMI, ACCJ, etc.), capture and share industry trends, represents JnJ’s position to shape regulatory environment for consumers’ health;
• Liaise with Government Affairs and help develop and execute external engagement strategies.
• OTC/ Quasi-drug/ Band Aid/Skin Health - portfolios assigned will be decided based on the background of candidate and business need

• Ensure timely and efficient registration for new products and product compliance for existing registrations. Prepare applications for registration of new products and variations to marketed products and rescheduling application, as required and maintain regulatory documentation and databases in line with J&J procedures.
• Critically analyze and provide regulatory strategy for data packages and ingredients for regulatory compliance or new products and identify discrepancies in data presented and request additional data.
• Assist in the development of labelling and develop product information in accordance with relevant regulations and codes.
• Suggest and implement improvements to processes and procedures to make the department more efficient.
• Build and maintain strong business partner relationships and attend Project Team meetings as required to ensure timely and accurate communication on projects. Provide cross functional support for other business areas as required.
• Develop and maintain strong relationships with government officials, and industry associations through attendance at meetings, conferences and seminars, as appropriate, to ensure compliance with the regulations, information sharing and influence is optimized in relation to individual product portfolios.
• Identify, review and disseminate information to relevant company personnel to ensure awareness and compliance with new regulations/codes and their subsequent amendments through the Regulatory Radar process.
• Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products. Review and provide Regulatory Affairs approval of advertising and promotional materials ensuring accuracy and compliance with codes of conduct. Include Medical Affairs when appropriate when developing new claims.
• Work with Manager by means of performance review system to define own strengths, weaknesses and aspirations and to plan activities that will benefit own development and company’s objectives. Assist in training and development of junior staff in the department, when required.