Lead Expert, Regulatory Affairs, HNC APAC

dsm-firmenich (Indonesia) (Jakarta, Jakarta, Indonesia)

DKI Jakarta, Indonesia

We are dsm-firmenich – innovators in nutrition, health, and beauty. We bring progress to life by combining the essential, the desirable, and the sustainable. From our master perfumers and flavorists to our expert nutritionists and scientists, our trailblazing teams work closely with customers, supporting their ambitions with 150+ years of R&D expertise. With a passionate and talented team of close to 30,000 employees, we are determined to be a force for good. And to work together to positively impact people and planet.

About this position

As a Regulatory Affairs Senior Specialist/Manager, you will be responsible for the product approval and maintenance of compliance in Indonesia for the entire Health, Nutrition & Care (HNC). You will also advise/ provide recommendations to Marketing and Sales, Product Management, Supply Chain, and Purchasing in all regulatory-related matters.

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.