Responsibility
- Regulatory Submissions:
- Prepare coordinate and submit regulatory dossiers /packaging data to the local authorities in Singapore
- Track submission progress and proactively address any queries or requests from the authorities.
- Provide timely updates monthly reports and KPI reports on submission status to the Regulatory Affairs Manager in Singapore.
- Documentation and Database Management:
- Compile organize and maintain comprehensive regulatory documentation including source of product registration and approvals.
- Ensure accurate and uptodate regulatory information is kept in relevant databases and systems.
- Compliance Support:
- Marketing claims: Maintain a current and accurate list of permitted and prohibited claims in accordance with local regulations. Review and ensure product claim compliance.
- Label: Ensure that all product labels comply with local labeling regulations and requirements.
- Inspection: Participate in local regulatory inspections including preparation and followup activities.
- Noncompliance reporting: Immediately report any identified regulatory risks or instances of noncompliance.
- Regulatory Monitoring:
- Monitor new regulations and guidelines relevant to the companys products.
- Provide timely updates and summaries of regulatory changes to the Regulatory Affairs Manager and relevant stakeholders.
- Assess the potential impact of new regulations on the companys products and operations.
Qualifications :
Diploma/degree with science background.
12 years of relevant working experience in regulatory affairs is preferred.
Excellent time management skills with the ability to thrive in a fastpaced environment.
A collaborative team player with strong interpersonal skills.
Meticulous with high level of accuracy.
Excellent communication skills both written and verbal.
Remote Work :
No
Employment Type :
Fulltime