Regulatory Affairs Manager

2 weeks ago


Kuala Lumpur, Malaysia Starco Consulting Sdn Bhd Full time

Initiate and coordinate relevant product submissions and/or notifications leading to timely approvals.
- Initiate and coordinate if any amendment (e.g. artworks change, etc.) submissions and approvals with relevant documents.
- Liaise with local regulatory authorities to deliver timely and commercially advantageous license or notification approvals
- Manage and respond to product regulatory questions.
- Develop and manage labelling text and packaging components to ensure compliance with local registered details and corporate prescribing information, as well as maximizing the commercial value of the label.
- Build effective working relationships with the regulatory agency and follow-up closely on approvals of product registration and amendments.
- Obtain all relevant Import/Export Licenses and maintain proper records in compliance with regulatory requirements.
- Provide support in crisis management and product recall.
- Monitor and report on regulatory projects and regulatory environment on a monthly basis.
- Supports marketing in providing regulatory information and updates.
- Ensure maintenance of all registration files for reference. Inform Logistics and respective Business Unit regarding registration approvals including relevant variations.
- To work closely with Project Management to obtain suitable components and finalize the desired component before start of compatibility testing.
- Any other assignments as identified by Management.

**Salary**: RM7,000.00 - RM10,000.00 per month

Schedule:

- Monday to Friday

Supplemental Pay:

- Performance bonus



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