Regulatory Affairs jobs in United Arab Emirates
SENIOR REGULATORY AFFAIRS EXECUTIVE
Jobstreet Malaysia
Regulatory Affairs & Product Compliance Manager
MR.DIY
Regulatory Pharmacists
Pharmasolution Sdn Bhd
Product Executive (Regulatory & Quality)
Hai-O
Global Regulatory & Product Compliance Lead
MR.DIY
Discover more opportunities than anywhere else. Find more jobs nowSenior Regulatory Affairs Leader (Pharma & PV)
Jobstreet Malaysia
Strategic Regulatory Pharmacist for Pharma & Devices
Pharmasolution Sdn Bhd
MDR Regulatory & Technical Documentation Lead
Bactiguard
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REGULATORY AFFAIRS EXECUTIVE (SIRIM)
Keleev Solutions Sdn Bhd
MDR Compliance & Documentation Specialist
Bactiguard
Senior Manager, Scientific Affairs APAC
Boston Scientific Gruppe
Senior Manager External Affairs
Philip Morris International
Malaysia Associate Director
Bower Asia Group
Senior Executive, Program Management and Implementation
Malaysian Communication and Multimedia Commission (MCMC)
Legal Manager (Legal & Compliance)
Central Medicare
Senior Executive, Regulatory (Telecommunication)
Perbadanan PR1MA Malaysia
Director Risk Transformation & Regulatory Enablement
Standard Chartered
Head of Risk Transformation & Regulatory Enablement
Standard Chartered
Special Officer, CEO Officer
Bjak Sdn Bhd
Senior Compliance & Regulatory Specialist
Tokio Marine Insurance Group
Senior Telecom Regulatory Lead
Perbadanan PR1MA Malaysia
Senior Executive, Regulatory (Telecommunication)
Perbadanan PR1MA Malaysia
SENIOR REGULATORY AFFAIRS EXECUTIVE
Job summary
A leading pharmaceutical company in Malaysia is seeking a Regulatory Affairs professional to provide regulatory expertise and ensure compliance with local regulations. Responsibilities include supporting the regulatory team, compiling product registration dossiers, and liaising with regulatory authorities. The ideal candidate should have a Bachelor's Degree in Pharmacy & Science and 2-5 years of experience in the Pharmaceutical industry. Proficiency in Microsoft Excel and fluency in English are essential.
Qualifications
- Minimum 2-5 years of relevant work experience in the Pharmaceutical industry.
- Strong understanding of the Pharmaceutical industry required.
- Relevant experience in Regulatory Affairs, especially in the Pharmaceutical & Medical industry.
Responsibilities
- Provide regulatory expertise to ensure compliance with local authorities.
- Support the Regulatory Affairs team in submitting applications.
- Compile dossiers for new product registration and renewals.
- Monitor product registration status and validity.
- Advise on regulatory requirements and strategy.
Skills
Education
Tools
Responsible for providing regulatory expertise to Regulatory Affairs Unit, Activ Pharma Sdn Bhd, and for ensuring the company’s Pharmaceutical and Medical Device operations are in compliance with the requirements of the local Regulatory Authorities.
Leading a subunit providing couch coaching mentoring to other Regulatory Affairs personnel.
Supporting the Regulatory Affairs team in submitting regulatory applications (submission, renewal, and variation) and obtaining timely approvals from the Regulatory Authorities.
Liaise with local Regulatory Authorities to expedite early regulatory approvals while developing and pursuing excellent working relationships.
Responsible for compiling dossiers in a timely manner for new product registration, product amendment, and product license renewal.
Monitor product registration status and ensure validity of registrations.
Maintain close liaison with regulatory authorities and overseas partners for all matters pertaining to registration and regulatory.
Support the teams by providing advice on regulatory requirements and strategy.
Other regulatory tasks as assigned by superior.
Responsible for instituting and maintaining the key aspects of Pharmacovigilance/Vigilance Management which consist of, but are not limited to, the following:
- Maintenance of local Pharmacovigilance System (PSMF)
- Preparation and maintenance of the standard operating procedures (SOPs) and other controlled quality documents
- Performing trend analyses, compliance checks, and predictive modelling for compliance operations
- Participating in Inspection/Audit, development of corrective action plans, and Corrective and Preventative Action (CAPA) implementation
Demonstrate strong understanding and expertise in the Pharmaceutical Industry.
Relevant experience in Regulatory Affairs, especially in the Pharmaceutical & Medical industry.
Proficiencies in Microsoft Excel & Quest3.
Ability to work in a team with attention to detail and able to work under pressure.
Demonstrate fluency in English, both written and spoken.
Bachelor's Degree in Pharmacy & Science with a minimum 2-5 years of relevant work experience in the Pharmaceutical industry.
* 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.