Conduct RA compliance reviews of dsm-firmenich’s products and manage dossier preparations for Product approvals in collaboration with Global or Regional Regulatory Affairs, Regional Business, Project Management, R&D functions, consultants etc. based on company strategy.
Submit dossiers to the local authorities, follow up on the approval process closely with evaluators and communicate progress in a timely manner to internal stakeholders.
Ability to conduct regulatory risk assessments, propose mitigation plans/ recommendations and contribute to process improvement activities, as needed.
Effectively prioritise and negotiate deliverables/ tasks in an agile and dynamic environment.
Proactive monitoring of changes in the regulatory environment, agile impact analysis and clear communication of the impact to the organisation.
Represent and advocate for dsm-firmenich externally, including but not limited to engagements with the Thai FDA, industry associations, and customers, as needed.
You bring
Minimum Bachelor’s degree in Pharmacy, Nutritional Science, Food Science or related disciplines and minimum 8 years of experience in regulatory affairs in food, food supplement and pharmaceuticals.
Strong working experience in Health/ Dietary/ Food Supplements, Food and Pharmaceuticals including Thai regulations, CODEX, EU Food Regulations, FCC, Pharmacopoiea, etc.
Demonstrated collaborative and influencing skills with internal colleagues, customers and relevant authorities across different functions and regions.
Good language skills (Thai, English & other languages a plus)
Able to integrate creative and business thinking in delivering regulatory solutions.
Capability to work effectively under pressure and in a matrix and dynamic organization.
Skills
Dietary Supplements
Pharmaceutical
Food Science
Functions
Research & Development
Job Overview
Job Type:
Hybrid
Company
dsm-firmenich
7 active jobs
Industry:
Other
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