Regulatory Affairs Manager, Health Nutrition & Care
About this position
Responsibilities
• 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 on time to internal stakeholders.
• Ability to conduct regulatory risk assessments, propose mitigation plans/ recommendations and contribute to process improvement activities, as needed.
• Effectively prioritize 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 BPOM, industry associations, and customers, as needed.
Requirements
• 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 BPOM regulations, CODEX, EU Food Regulations, FCC, Pharmacopoiea, etc. Experience outside Indonesia is desirable.
• Demonstrated collaborative and influencing skills with internal colleagues, customers and relevant authorities across different functions and regions.
• Good language skills (Bahasa Indonesia, 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.