Ra Specialist

Job Duties:

- Prepare and maintain a listing of all registered products in all markets and maintain its renewal in a timely manner. Working closely with market authorized representative by providing all the necessary documents for dossier submission. Keeping track of legislation changes and advise on the legal and scientific restraint and requirements, collect, collate and evaluate scientific data.
- Ensure local and international market regulatory requirements are in compliance (HSA, TGA, FDA, EU, others as applicable).
- Participate in regulatory inspection by the regulatory authorities and certification bodies.
- Participate and assist to provide material/information required by Regulatory Authority for import, reimbursement and product registration.
- Ensure all technical documents are updated and ready for regulatory submission. Update when necessary.
- Working closely with market Authorized Representative to ensure products marketed are safe, sterile and effective.
- Any other tasks or projects that are being assigned by the immediate supervisor, as and when required.

Job Requirements:

- Diploma/Degree in Life Science (Pharmacy, Biology, Chemistry, Pharmaceutical).
- In-depth knowledge of the cGMP, market regulations (HSA, FDA, TGA, CFDA, EU) and ISO 13485.
- Understanding of law, regulation and pending regulation. Good communication, technical writing and interpersonal skills.
- Read, write and speak Chinese

**Salary**: RM10,500.00 - RM12,000.00 per month

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Johor Bahru: Reliably commute or planning to relocate before starting work (required)

**Language**:

- Mandarin (required)