Regulatory Affairs Executive
2 weeks ago
The company I’m representing is a leading consumer healthcare MNC with a good presence globally. They are looking for a Regulatory Affairs Specialist to help with their product registrations across the ASEAN region. This incumbent would have opportunities for career progression internally.
**Responsibilities**:
- To prepare and track overall regulatory projects & timelines to monitor potential bottle necks in registration matters and to assist in developing or improving submission strategies.
- To communicate with internal & external stakeholders on documentation requirements for regulatory submissions of new/ existing products; to review and compile dossier package before official submission.
- To perform labelling checks and highlight discrepancies against stipulated label requirements of the respective import & export country and/or inconsistency with other markets.
- To research and obtain regulatory information from Authorities for new/existing countries and present findings and recommendation to the top management and relevant stakeholders.
**Job Requirements**:
- A good Degree in Chemistry/Pharmacy/Microbiology/Science.
- Minimum 2 years of relevant working experience in Regulatory environment for health product or OTC pharmaceutical products.
- Familiar with ASEAN regulatory guidelines.
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