Senior Specialist, Regulatory Affairs

How You Will Contribute

• Support to existing product portfolio in their food, dietary supplement and pharmaceutical, providing expertise and insight on regulatory procedures and requirements to ensure regional compliance and timelines are met.
• Develop, submit and support the dossiers for new registration or renewal of food and pharmaceutical excipients.
• Interface with local competent authorities and industry associations, to understand regulatory issues of direct impact to the use of IFF products that are used in finished drug products and assist with their implementation.
• Maintain a close interaction with regional business teams to identify needs, align on regional objectives and prioritize the efforts. Provide regional strategic input to global strategies and innovation.
• Act as primary local regulatory interface for customers – including regulatory interpretations, defending positions, supporting briefs, launches and provide regulatory support for customer and distributor’s regulatory filings as needed.
• Help ensure that relevant risk evaluation and management processes are followed and completed.
• Be able to extend the role to support cross-product line projects.

Job Requirements

Preferred Experience & Qualifications

• Expert and hands-on knowledge on Thailand regulatory landscape for food ingredients, pharma excipients and their use in finished products.
• Experience in interaction with regulatory agencies and track record in product clearance/registrations and regulatory advocacy.
• Bachelor+ degree in chemistry, Biochemistry, Food Science, Nutrition, Pharmaceutical Science or similar fields.
• Minimum 5 years regulatory affairs work experience in the industry of food ingredients, chemical, pharmaceutical excipients or finish products.
• Strong project management competencies to handle multiple projects simultaneously, prioritizing workload to meet multiple deadlines.
• Strong influencer and collaborator with interdisciplinary teams.
• Excellent interpersonal and communication skills including strong verbal and written skills in English.
• Sound experience of computer information systems.