Monitor applicable regulations or guidelines and translate into comprehensive action plans to ensure compliance of the product portfolio in scope. Develop and maintain systems for proper implementation with internal stakeholders.
Manage customer and authority requests related to regulatory and compliance with the aim to increase customer delight and to ensure compliance.
Collaborate with company internal network to obtain necessary product documentation (e.g. from global production sites outside SEA) in support of local regulatory projects and customer requests.
Support Marketing, R&D and Business Development in ad hoc projects, in relation to market growth and innovation initiatives by preparing SEA regulatory assessments for relevant regulatory topics of interest, and through review of Marketing Communication materials for SEA countries with regard to local regulatory compliance.
Support Logistics by determining the regulatory requirements related to export / import of the product portfolio in scope from and to the SEA region. Where needed, liaise with local and foreign authorities to come to an agreement for the correct export / import certificate.
Support sales by ensuring regulatory assessment for compliant marketing of Dosage Form Solution products in the SEA region such as determining appropriate regulatory and quality standards for the intended use.
Support collaboration with Halal authorities and certification bodies in Thailand to ensure solutions for market requirements and to maintain required certifications.
Where relevant, participate to value adding industry conferences as well as required external and internal regulatory expert networks or trade associations in the SEA region.
Perform other duties that are aligned with the incumbent’s skills, experience and competencies as assigned. These other duties cannot compromise the employee’s wellbeing and workload.
Qualifications
Bachelor Degree in Chemical or Food Science.
Substantial years of relevant experience working in a Multi-National environment.
Work experience from the Health, Food supplement industry.
Hands-on RA experience with good understanding of local registration requirements and the related safety issues.
Good understanding of the local culture, government bodies/ agencies and the ability to gather key market intelligence & advocate.
Proven track record in providing recommendations to resolve registration challenges.
Excellent business partnering skills and proven track record in supporting Sales team.
Self-starter who is able to work across functions, regions and with excellent communication skills.
