Job Description

 Regulatory Affairs

• Responsible for timely registration of new formulations/products (local and overseas).
• Responsible for renewal of product license with National Pharmaceutical Regulatory Agency (NPRA) and overseas regulatory authority.
• Responsible for product registration amendment with the necessary documents.
• Follow up on regulatory correspondences with relevant parties and reply within agreed timeline.
• Responsible for the application for Health Certificate, Certificate of Pharmaceutical Product, Halal Certificate and endorsement of document with the related authority.
• Keeps abreast with the latest regulatory requirements (local & overseas). Notify Regulatory & Product Development Manager as appropriate and in a timely manner.
• Maintains all regulatory documents in an organised manner and in safe custody.
• Coordinating the necessary product analysis with external accredited laboratory for registration and export purpose.
• Issuance of Regulatory Alert to all the related department.

Coordination of OEM Projects

• Assist Regulatory & Product Development Manager/Assistant in coordinating the new product development/product quality improvement for nutrition products with contract manufacturers.
• Responsible for the maintenance of contract manufacturer’s related certification records (halal cert, QMS, registration license, etc.)
• Assist in coordinating documentation request for registration with respective contract manufacturer.
• Liaise with relevant department to confirm and/or finalize the agreements for contract manufacturing activities. Retain a copy of the signed agreements and ensure all agreements are in force for all active contract manufacturers.
• Ensure all correspondence and records for contract manufacturing is properly filed for easy reference and traceability.
• Provide supporting information to marketing team for OEM product launching/enquiries reply.
• Issue memo to related departments for update relevant to OEM products.

Others

• Assist Regulatory & Product Development Manager in conducting product training (jointly with Marketing Department) for sales and marketing staff.
• Assist Regulatory & Product Development Manager in sourcing of information pertaining to product or regulatory requirement.
• To comply and work towards meeting the company’s quality policy; health, safety and environment objectives and policies; and quality system requirements.
• To complies Good Documentation Practice.
• To participate in internal quality audit and other relevant audit. 

Job Requirements

1. Degree in Pharmacy, Applied Science, Science Nutrition or any related discipline.
2. Excellent communication skills (spoken and written in English and Bahasa Malaysia) and interpersonal skills.
3. Basic computer skills such as Microsoft Office, etc.

Skills