About This Role
This specialist role in Regulatory Affairs is central to the RA & QA team's operations, coordinating all regulatory activities to ensure smooth and consistent team function. The role involves supporting and coaching RA & QA Officers, aligning regulatory SOPs with global standards, and shaping regulatory strategies for projects. You will also serve as a link between manufacturing sites, customers, and internal teams, managing information flow and providing regulatory support.
Responsibilities
- Organize and coordinate all regulatory activities, ensuring the team works smoothly and consistently
- Support and coach RA & QA Officers
- Keep regulatory SOPs aligned with Ajinomoto Co., Inc. global standards
- Help shape regulatory strategies for new and ongoing projects
- Work closely with Ajinomoto affiliates and key customers, representing Ajinomoto in regulatory discussions
- Manage information flow within the RA department, ensuring accuracy, traceability, and timely delivery
- Provide clear regulatory support to customers, guiding them through complex topics
- Prepare and validate regulatory and quality statements for customers
- Coordinate change control activities from A to Z: communication, documentation, approvals, and follow-up
- Ensure readiness for customer audits
- Help safeguard the quality and reliability of distribution activities
- Approve material code allocations for customers
- Manage customer complaints with professionalism and a solution-oriented mindset
- Establish and maintain quality agreements with customers, suppliers, distributors, and subcontractors
- Perform regulatory assessments for projects initiated by AASO or Ajinomoto globally
- Anticipate customer needs and regulatory expectations, contributing to a proactive strategy
- Participate in internal, global, and customer project meetings and ensure all regulatory aspects are followed up thoroughly
Requirements
- Master's degree in a scientific field (Industrial Pharmacist, Chemist, Bio-Engineer, Industrial Engineer, …)
- 5–10 years of experience in Regulatory Affairs and exposure to Quality Assurance within the pharmaceutical or related industries
- Methodical, accurate, and structured in approach
- Strong ability to assess situations realistically, identify risks, and propose balanced solutions
- Clear helicopter view, able to oversee processes across the entire organization and its external partners
- Proven project management capabilities
- Effective communicator in English (spoken and written); additional languages are an asset
- Resilient under pressure, able to set the right priorities and meet deadlines
