シニアレギュラトリーアフェアーズアソシエイト/ Senior Regulatory Affairs Associate

A multinational consumer health company is looking for a Senior Regulatory Affairs Associate. The selected candidate will manage regulatory submissions and compliance activities, develop regulatory strategies, support product approvals, and drive regulatory intelligence, training, and technology-enabled process improvements.

Responsibilities:

• Develop and implement regulatory strategies to streamline product approvals while ensuring compliance with global standards
• Collaborate with R&D and Marketing teams to translate regulatory requirements into product labelling and communication strategies
• Lead the creation of regulatory intelligence reports to anticipate industry shifts and support proactive policy adaptation
• Design and deliver training modules to strengthen regulatory awareness and agility across the organisation
• Integrate emerging digital tools and AI-driven analytics to improve regulatory submission accuracy and efficiency
• Manage regulatory submissions and ensure compliance with applicable laws and guidelines
• Support product approvals through cross-functional collaboration
• Maintain regulatory documentation and ensure regulatory requirements are effectively communicated

Requirements:

• Bachelor’s degree or above in a relevant scientific or regulatory field
• More than 3 years of experience in regulatory affairs or a related domain
• Strong understanding of regulatory guidelines and compliance requirements
• Proven ability to interpret and synthesise scientific data
• Effective communication skills for preparing regulatory documentation

Preferred requirements:

• Master's degree or above in a relevant science
• Experience in the consumer industry, including OTC drugs, quasi-drugs, cosmetics, consumer medical devices, or food
• Experience using English in a multinational or domestic company
• Expertise in navigating complex regulatory landscapes with innovative problem-solving
• Experience crafting persuasive regulatory narratives and stakeholder presentations
• Proficiency in leveraging technology and data analytics for regulatory process improvement
• Strategic foresight in regulatory affairs and compliance monitoring
• Possess a valid Pharmacist qualification
• Proficient in English (TOEIC 700+)

About the Company:

This company operates in the consumer health industry, with products and activities spanning areas including OTC drugs, quasi-drugs, cosmetics, consumer medical devices, and food. It operates in a global regulatory environment focused on product compliance and approvals.

Keywords:

シニア規制関連アソシエイト, 薬事, 規制関連業務, 薬事申請, 規制対応, 法規制遵守, 規制戦略, 規制インテリジェンス, 製品承認, 製品表示, コンシューマーヘルス, OTC医薬品, 化粧品, 医療機器, データ分析, 求人, 外資系

Job Ref: MIL6TP