EN
9,672
Regulatory Affairs jobs in Malaysia
Executive Regulatory Affairs
DKSH Group
Petaling Jaya
On-site
MYR 60,000 - 80,000
Yesterday
Be an early applicant
I want to receive the latest job alerts for “Regulatory Affairs” jobs
Regulatory Affairs & Product Compliance Manager
MR D-I-Y Malaysia
Seri Kembangan
On-site
MYR 90,000 - 120,000
Today
Be an early applicant
Regulatory Affairs Specialist
Bright Prospect
Selangor
On-site
MYR 40,000 - 60,000
Yesterday
Be an early applicant
Regulatory Affairs Senior Executive
TERAJU PHARMA Sdn Bhd
Klang City
On-site
MYR 200,000 - 250,000
Yesterday
Be an early applicant
Discover more opportunities than anywhere else. Find more jobs nowFinance Executive
Zico Trust (M) Berhad
Selangor
On-site
MYR 100,000 - 150,000
Yesterday
Be an early applicant
Product Compliance Executive (Asia Pacific)
MR DIY International
Seri Kembangan
On-site
MYR 40,000 - 60,000
Yesterday
Be an early applicant
Manager, Shariah Compliance (GETB)
Great Eastern
Kuala Lumpur
On-site
MYR 60,000 - 80,000
Yesterday
Be an early applicant
Connect with headhunters to apply for similar jobsSenior Analyst - Regulatory & Risk Reporting
RBC
Kuala Lumpur
Hybrid
MYR 80,000 - 120,000
2 days ago
Be an early applicant
SR&T Risk Quantitative Analyst (Regulatory & Financial Risk)
Deloitte Malaysia SR&T Solutions Sdn Bhd
Kuala Lumpur
On-site
MYR 60,000 - 80,000
2 days ago
Be an early applicant
Compliance & Driver Operations Associate – ShopeeFood
gradmalaysia.com
Kuala Lumpur
On-site
MYR 100,000 - 150,000
2 days ago
Be an early applicant
Senior Regulatory Affairs Specialist, APAC
ZOLL Medical Corporation
Selangor
On-site
MYR 70,000 - 90,000
7 days ago
Be an early applicant
Regulatory Affairs Executive (Ipoh or PJ)
Hovid
Selangor
On-site
MYR 40,000 - 60,000
7 days ago
Be an early applicant
SENIOR REGULATORY AFFAIRS EXECUTIVE
Jobstreet Malaysia
Selangor
On-site
MYR 70,000 - 90,000
6 days ago
Be an early applicant
Regulatory Affairs Executive
Biovista Lifesciences
Selangor
On-site
MYR 200,000 - 250,000
7 days ago
Be an early applicant
Account Cum Finance Manager
SHIAN LIANG PETROLEUM SDN. BHD.
Kuching
On-site
MYR 100,000 - 150,000
2 days ago
Be an early applicant
Senior Executive, Regulatory Affairs
DKSH
Selangor
On-site
MYR 100,000 - 150,000
7 days ago
Be an early applicant
Executive Regulatory Affairs
DKSH
Selangor
On-site
MYR 200,000 - 250,000
7 days ago
Be an early applicant
Regulatory Affairs Advisor
Michael Page
Kuala Lumpur
On-site
MYR 100,000 - 150,000
7 days ago
Be an early applicant
Regulatory Affairs
Intrinseque Health
Malacca City
On-site
MYR 50,000 - 70,000
7 days ago
Be an early applicant
Regulatory Affairs & Product Compliance Manager
MR.DIY
Selangor
On-site
MYR 90,000 - 120,000
6 days ago
Be an early applicant
Regulatory Affair Executive
Intrinseque Health
Malacca City
On-site
MYR 200,000 - 250,000
7 days ago
Be an early applicant
Executive Regulatory Affairs
DKSH Group
Petaling Jaya
On-site
MYR 60,000 - 80,000
Full time
2 days ago
Be an early applicant
Job summary
A leading healthcare service provider in Petaling Jaya is seeking an Executive in Regulatory Affairs. The role involves assisting in regulatory submissions, ensuring compliance with Malaysian regulations, and liaising with local authorities. Candidates must have a Bachelor's Degree in Pharmacy and proficiency in quality assurance tools. The position offers opportunities to engage with clients and support pharmacovigilance activities, ensuring timely reporting and maintenance of necessary licenses.
Qualifications
- Bachelor's Degree in Pharmacy is required.
- Knowledge of Global Harmonized System (GHS) is an advantage.
- Ability to liaise with local Regulatory Authorities.
Responsibilities
- Assist in timely variation submission via NPRA Quest system.
- Ensure compliance with government regulations.
- Conduct pharmacovigilance activities and report Adverse Drug Events.
- Supervise discharge of psychotropic drugs and maintain licenses.
Skills
Knowledge of quality assurance tools
Understanding of Dangerous Goods Regulations
Proficient in office productivity tools (Excel, Word, PowerPoint)
Fluency in local language and English
Education
Bachelor's Degree in Pharmacy
Job description
Executive Regulatory Affairs
Location: Petaling Jaya, MY, MY
Global Business Unit: HEC
Job Function: Regulatory Services
Requisition Number: 219489
Job Summary
Assist Regulatory Affairs Pharmacist to cover regulatory affairs matters of DKSH Malaysia Sdn Bhd, Business Unit Healthcare.
General Responsibilities
Regulatory Affairs
- Assist in timely variation submission via NPRA Quest system for pharmaceutical products. As well as product registration maintenance and document retention.
- Keep abreast of updated regulations in Malaysia
- Liaise with local Regulatory Authorities to expedite early regulatory approvals while developing and serve as the official and full time liaison personnel with the government’s regulatory agencies and Ministry of Health.
- Ensure proper documentation of all regulatory applications and communications with clients & Regulatory Authorities
- Ensure DKSH (M) operations are in compliance with all applicable government laws and regulations.
- Ensure services provided are as agreed in RA agreement with Clients.
- Review promotional material, where DKSH as license holder, to ensure contents are fully supported by the Product Information and literature, and in accordance with the PhAMA Code of Conduct and authority’s guideline.
Pharmacovigilance (PV)
- Acts as local Pharmacovigilance associate supporting Primary Pharmacovigilance responsible person (RPPV).
- Liaises with Client PV contact persons for timely reporting of Adverse Drug Events and submitting these reports within the stipulated timelines.
- Liaises with Client PV contact persons for medical device expedited reporting.
- Performing periodic literature and NPRA MADRAC/Journal search.
- Maintain Pharmacovigilance Log, Periodic Safety Updates Report Logs and Product Safety Core Data Sheet
- Responsible for reconciliation of PV logs with clients
Registered Pharmacist
- Responsible for supervising the discharge of psychotropic drugs
- Ensure company’s operations are in compliance with all Ministry of Health’s laws and regulations. Maintenance of the various licenses required to operate DKSH’s warehouse and distribution services.
Functional Skills and Knowledge
- Demonstrate knowledge in quality assurance tools, concepts and methodologies
- Demonstrate good knowledge in Dangerous Goods Regulations and Safety Data Sheets (SDS)
- Demonstrate basic understanding of the Global Harmonized System (GHS)
- Demonstrate good working knowledge, comprehension and applications of local regulations
- Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
- Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
- Demonstrate fluency in local language and ideally in English, both written and spoken
Education
- Minimum Bachelor's Degree in Pharmacy.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.