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About the Role
The Senior Regulatory Affairs Associate is responsible for managing regulatory submissions and ensuring compliance with applicable laws and guidelines. You will collaborate with cross-functional teams to support product approvals and maintain regulatory documentation.
Responsibilities
- Pioneer the development and implementation of cutting-edge regulatory strategies that streamline product approvals while ensuring full compliance with global standards.
- Collaborate cross-functionally with R&D and marketing teams to translate complex regulatory requirements into innovative product labeling and communication strategies.
- Lead the creation of dynamic regulatory intelligence reports that anticipate industry shifts and proactively adapt company policies.
- Design and execute interactive training modules to elevate regulatory awareness and agility across the organization.
- Champion the integration of emerging digital tools and AI-driven analytics to enhance regulatory submission accuracy and efficiency.
Requirements
- Bachelor's degree in a relevant scientific or regulatory field
- Minimum of 3 years experience in regulatory affairs or related domain
- Strong understanding of regulatory guidelines and compliance requirements
- Experience in regulatory affairs for OTC pharmaceutical products
- Proven ability to interpret and synthesize scientific data
- Effective communication skills for preparing regulatory documentation
- Work experience using English in Multinational company or domestic company (TOEIC 700 or more)
- Pharmacist or master degrees in a relevant science
- Work experience in Consumer industry (OTC drugs, Quasi-drugs, Cosmetics, Medical devices for consumer use, food, etc)
- Expertise in navigating complex regulatory landscapes with innovative problem-solving
- Experience in 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
- Proactive approach with a commitment to continuous learning and pioneering novel regulatory methods
Skills
- Regulatory Affairs
- Product Approvals
- Regulatory Documentation
- Regulatory Strategies
- Global Standards
- R&D Collaboration
- Marketing Collaboration
- Regulatory Requirements Translation
- Product Labeling
- Communication Strategies
- Regulatory Intelligence
- Policy Adaptation
- Training Module Design
- Regulatory Awareness
- Digital Tools Integration
- AI-driven Analytics
- Submission Accuracy
- Submission Efficiency
- Scientific Data Interpretation
- Scientific Data Synthesis
- Regulatory Documentation Preparation
- English Proficiency
- Consumer Industry Experience
- Problem-Solving
- Stakeholder Presentations
- Data Analytics
- Compliance Monitoring
- Continuous Learning
- Novel Regulatory Methods
Location
- Asia Pacific
- Japan
- Tokyo-To
- Chiyoda
Work Type
- Hybrid
Experience Level
- Senior
- Minimum of 3 years experience
Education Level
- Bachelor's degree in a relevant scientific or regulatory field
- Pharmacist or master degrees in a relevant science
About the Company
- At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.
- Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours.
Equal Opportunity
- If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.