Covers a wide range of medical, dental, and vision expenses to keep you and your family healthy.

Comprehensive Health Insurance

Enjoy vacation days, personal leave, and holidays to relax and recharge without losing income.

Paid Time Off

Helps you prepare for the future with employer-matched contributions to your retirement fund.

Retirement Savings Plan

Access to training programs, workshops, and seminars to enhance your skills and career growth.

Professional Development Opportunities

Provides confidential support for personal and professional challenges, including counseling services.

Employee Assistance Program

KOTRA PHARMA (M) SDN BHD

At Kotra Pharma, we are dedicated to maintaining top-of-the-line research in order to remain at the forefront of healthcare technology and innovation. The establishment of our research facility in Melaka is a testament of our commitment to continuously create innovative, high quality products aimed at improving health and enhancing holistic well-being.

About Us

<h2>Our Vision</h2>
<h4>Everyone deserves a healthier tomorrow.</h4>
We believe healthcare is a basic right of everyone. We believe our human capital and technology can innovate and improve the availability of our healthcare products to meet the healthcare needs of society

<h2>Our Mission</h2>
Manufacturing Excellence: To continuously meet the world standard in pharmaceutical manufacturing
Research and Development Excellence: To continuously invest not less than 3% of our sales revenue into the enhancement of our research and development
Global Pharmaceutical Excellence: To be available in four continents by 2030 (Africa, Europe, Asia and Australia)
Brand and Marketing Excellence: To be a trusted household name in countries where we have a presence
People Excellence: To be The Reference Centre for Talent Development and People Excellence

Our Vision & Mission

&nbsp;<ins>Regulatory Affairs</ins>
<ul>
<li>Responsible for timely registration of new formulations/products (local and overseas).</li>
<li>Responsible for renewal of product license with National Pharmaceutical Regulatory Agency (NPRA) and overseas regulatory authority.</li>
<li>Responsible for product registration amendment with the necessary documents.</li>
<li>Follow up on regulatory correspondences with relevant parties and reply within agreed timeline.</li>
<li>Responsible for the application for Health Certificate, Certificate of Pharmaceutical Product, Halal Certificate and endorsement of document with the related authority.</li>
<li>Keeps abreast with the latest regulatory requirements (local &amp; overseas). Notify Regulatory &amp; Product Development Manager as appropriate and in a timely manner.</li>
<li>Maintains all regulatory documents in an organised manner and in safe custody.</li>
<li>Coordinating the necessary product analysis with external accredited laboratory for registration and export purpose.</li>
<li>Issuance of Regulatory Alert to all the related department.</li>
</ul>
<ins>Coordination of OEM Projects</ins>
<ul>
<li>Assist Regulatory &amp; Product Development Manager/Assistant in coordinating the new product development/product quality improvement for nutrition products with contract manufacturers.</li>
<li>Responsible for the maintenance of contract manufacturer’s related certification records (halal cert, QMS, registration license, etc.)</li>
<li>Assist in coordinating documentation request for registration with respective contract manufacturer.</li>
<li>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.</li>
<li>Ensure all correspondence and records for contract manufacturing is properly filed for easy reference and traceability.</li>
<li>Provide supporting information to marketing team for OEM product launching/enquiries reply.</li>
<li>Issue memo to related departments for update relevant to OEM products.</li>
</ul>
<ins>Others</ins>
<ul>
<li>Assist Regulatory &amp; Product Development Manager in conducting product training (jointly with Marketing Department) for sales and marketing staff.</li>
<li>Assist Regulatory &amp; Product Development Manager in sourcing of information pertaining to product or regulatory requirement.</li>
<li>To comply and work towards meeting the company’s quality policy; health, safety and environment objectives and policies; and quality system requirements.</li>
<li>To complies Good Documentation Practice.</li>
<li>To participate in internal quality audit and other relevant audit.&nbsp;</li>
</ul>

This job is all about ensuring that new products meet legal standards before reaching the market. You might like this job because it involves teamwork, keeping up with regulations, and helping develop health products that can improve lives!

Regulatory Compliance

Regulatory Affairs

Product Registration

Pharmaceuticals

 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, Cer...

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KOTRA PHARMA (M) SDN BHD