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- Coordinate BE clinical studies, manage CRO queries and study documents.
- Support BE programmes for products manufactured or contract-manufactured.
- Own licence filings, PSUR/RMP/PSMF updates, training and audits, high regulatory exposure!
Job Description
- Coordinate clinical studies (bioequivalence (BE) studies) of products manufactured/ contract manufactured by Kotra Pharma. To adhere to project milestone in order to assure timely submission of new products.
- Act as contact point with the Contract Research Organization (CRO) for queries pertaining to registering and maintaining product licenses. Always respond and attend to queries forwarded by Senior RE/ RE (i.e. posted by regulatory authorities) in a timely manner. Senior RE/ RE will be the contact point with regulatory authorities.
- Responsible for application of license and variations (if require) of Clinical Trial Exemption (CTX) and Clinical Trial Import Licence (CTIL).
- Maintains all study documents in an organised manner and in safe custody.
- Issuance of Regulatory Alert to all the related department.
- Responsible for preparation and update of Periodic Safety Update Report (PSUR), Risk Management Plan (RMP), Pharmacovigilance Site Master File (PSMF) and other pharmacovigilance related documents.
- To assist in implementing regulatory requirements and impart information about the current approach of regulatory authorities to relevant departments in Kotra Pharma.
- Assist Regulatory & Product Development Manager in conducting training pertaining to BE, PSUR and RMP for internal staff or external.
- 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 and Good Clinical Practice.
- To participate in internal quality audit and other relevant audit.
Job Requirements
- Bachelor Degree in Pharmacy, Applied Science, Science Nutrition or any related discipline.
- Excellence communication skills (spoken and written in English and Bahasa Malaysia) and Interpersonal skills.
- Basic computer skills such as Microsoft Office, etc.
Skills
Good Documentation Practices
Company Benefits
Comprehensive Health Insurance
Covers a wide range of medical, dental, and vision expenses to keep you and your family healthy.
Paid Time Off
Enjoy vacation days, personal leave, and holidays to relax and recharge without losing income.
Retirement Savings Plan
Helps you prepare for the future with employer-matched contributions to your retirement fund.
Professional Development Opportunities
Access to training programs, workshops, and seminars to enhance your skills and career growth.
Employee Assistance Program
Provides confidential support for personal and professional challenges, including counseling services.
Additional Info
Company Activity
Last active - few hours ago
Experience Level
1 - 3 Years of Experience
Career Level
Junior Executive
Job Specialisation
Company Profile
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.