JOB DETAILS Position : Regulatory Affairs & Quality Assurance Manager
Company Industry : Pharmaceutical
Working Hours : Monday to Friday (0800 hour to 1730)
Working Location : Jalan Universiti, 46200 Petaling Jaya, Selangor Darul Ehsan, Malaysia
Working Mode: Hybrid ( 3 WFH 2 WFO)
Working Duration: 24 months contract with PERSOLKELLY (renewal based on performance)
Remuneration : Salary up to RM8,000 to RM12,000 (based on qualification & experience) with statutory contribution + leave entitlement + insurance & medical coverage
WHO CAN APPLY? Degree in PharmacyA registered pharmacist in MalaysiaFluency in English and Bahasa MelayuAt least 5 years of Regulatory Affairs working experienceDirect experience of working with Regulatory AuthoritiesKnowledge of international guidelines and national legistration related to drug and medical device registration, and pharmacovigilanceExperience with ASEAN regulations would be ideal.Capable of developing and implementing regulatory strategies.Strong communication skillsCompetency in cross-functional collaborations. JOB SUMMARY You will primarily be responsible for ensuring sound regulatory strategies for assigned products are formulated and executed to support the business goals of the Malaysia and Brunei.
JOB SCOPE : Obtain fast new drug approvals through preparation of the required documentation and thorough follow-up with local health authorities.Variations and renewals of already approved drugs.Proactively identify regulatory trends and communicate potential impacts on company business.Adhere strictly the timelines in Corporate SOP for submitting the registration information to Regulatory Information Management System (RIMS) Data Entry Team and verifying RIMS data.Preparation of technical dossiers for price submission and tender applicationProcessing and reporting to Global Safety and Health Authorities all safety information received from market, post-authorisation studies, scientific literature and Health Authorities in accordance with national legislation and internal procedures.Manage the product quality complaint process and handle product recalls.Provide training to all employees and local agent(s) with regard to safety reporting, complaint management, and product recall.Perform disposition of finished products for distribution or delegate the task to appropriate trained individuals.Provide QA oversight of activities performed by distributor.Act as the Management Representative to ensure that the processes needed for the local quality management system are established, implemented and maintained.Responsible for Malaysia and Brunei markets.Act as Local Safety Officer (LSO) for the Malaysia subsidiary. HOW TO APPLY? Interested candidates for the position are encouraged to send their resumes to Persolkelly at the following email address : [email protected]