Lead Expert, Regulatory Affairs, Hnc Apac

4 days ago

Jakarta, Indonesia DSM Full time

**J**ob title** - Lead Expert, Regulatory Affairs, HNC APAC

**Location** - Jakarta, Indonesia

**Job model**- Hybrid

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. You will render regulatory-specific support to marketing and sales for customer-related activities, including customer presentations/ workshops, alignment of customer quality agreements and specifications sign-off.

At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.

**Your key 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.

**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 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.

**We bring**
- Empowerment to make meaningful contributions while upholding ethical standards;
- Recognition and celebration of your efforts and accomplishments;
- Opportunities for growth and advancement for those who embrace innovation and take initiative;
- Collaboration with experts in health, nutrition, and beauty to drive progress;
- Opportunity to build a career making a significant impact on billions of lives, with the freedom to shape your own path;
- Responsibility and accountability in living company values and driving sustainable solutions;

**Equal Opportunities Commitment**

dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate, there’s a place for everyone at dsm-firmenich.

dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. dsm-firmenich people are as diverse as our customers. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.

We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.

**About dsm-firmenich**

As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amster

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