Regulatory Executive

1 week ago

Bukit Mertajam, Malaysia SKY RESOURCES SDN BHD Full time

Assist in interpreting regulatory requirements and impart information about the current approach of regulatory authorities to relevant departments in the company, and make recommendations to management with regards to regulatory approach.
- Prepare, submit, register and support product registration to regulatory authorities on timely manner, inclusive but not limit to PIF (Product Information File) for cosmetics products.
- Ensure and controlled documents and records in compliance with regulatory requirements and company standards.
- To liaise with Regulatory Authorities for product complaints, recalls and renewal
- To assist RA/QA on daily activities ranging from regulatory, quality, compliance and provide regulatory support internally.
- To support customers’ enquiries/requests in relations to Regulatory and Registration.
- Contact person of any queries pertaining to registering and maintaining products license, product complaints, recalls and renewal from regulatory authority officials, respond and attend to queries posted by regulatory authorities in a timely manner.
- Participate in new product development, quality assurance, manufacturing and marketing team projects as to ensure all practices and outcomes are complied with regulatory requirements.

**; Requirements**:
- Minimum Diploma or Degree in related field of studies with mínimal of 3 years proven experiences in regulatory affairs within healthcare and/or cosmetics industry.
- Relevant experience in direct interaction with regulatory authorities.
- Strong prioritization, planning, organizing and executing.
- Possess high levels of accuracy and attention to details.
- Good interpersonal skills
- Knowledge in ISO, GDPMD control/regulatory Halal, NOT, Product Classification, etc. will be an added advantage.

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