Regulatory Affairs Executive
Regulatory Affairs Executive
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Job Description
Responsibility
Regulatory Submissions:
Prepare coordinate and submit regulatory dossiers and applications to the Indonesian regulatory authorities (e.g. BPOM).
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 Indonesia.
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 Indonesian labeling regulations and requirements.
Inspection: Assist the Regulatory Affairs Manager in Indonesia during local regulatory inspections including preparation and followup activities.
Regulatory Monitoring:
Monitor new Indonesian 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.
- Preferable with 23 years of working experience in regulatory areas.
- Good in time management and able to work in a fastpaced work environment
- A good team player.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
