Regulatory Affairs Specialist

4 weeks ago


Shah Alam, Malaysia Yes Health Sdn Bhd Full time

To prepare compilation of pharmaceutical product dossier submission to NPRA and follow through with subsequent correspondence until approval to formalize changes requiring regulatory submission initiated in the company.
- To be the person in charge/coordinator for variation related activities in the department. Responsible to ensure full adherence to variation submission procedures including monthly report generation, maintenance of tracker, etc.
- Responsible for document submission to relevant regulatory authorities, and attending to related queries i.e. both from internal and external sources.
- To assist in preparing the relevant departmental processes in standard operating procedures, work instructions.
- To keep updated on current regulatory requirements as and when it is made available by the regulatory authorities.
- Coordinated and assist inter-department product information requests.
- To review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- To assist superior to participate in all projects undertaken by the team intra and inter-departmental where required.
- Any other duties that may be assigned by Management from time to time.

**Job Requirements**:

- At least 1 year (s) of working experience in the related field is required for this position.
- Good Command of English and Bahasa Malaysia.
- Proficient with NPRA Quest3+, MS Office, and relevant regulatory system software.
- Effective management skills in retrieving information for supporting regulatory activities and comprehending guidelines and requirements.
- Self-motivated, meticulous, detail-oriented, able to multitask, and a good team player.
- **Fresh Graduates are welcome to apply.



  • Shah Alam, Malaysia EPS Ventures Sdn Bhd Full time

    **Key Responsibilities**: **1. Regulatory services & Pharmacovigilance & handling of controlled drug** - Review and approve marketing and promotion materials. Handle registration and maintain database of sales and advertisement permits issued by relevant authority bodies. - Responsible for the Regulatory Affairs (RA) functions and team members. - Provide...


  • Shah Alam, Malaysia EPS Ventures Sdn Bhd Full time

    **Key Responsibilities**: **1. Regulatory services & Pharmacovigilance & handling of controlled drug** - Review and approve marketing and promotion materials. Handle registration and maintain database of sales and advertisement permits issued by relevant authority bodies. - Responsible for the Regulatory Affairs (RA) functions and team members. - Provide...

  • Regulatory Affairs

    3 weeks ago


    Shah Alam, Malaysia Kino Biotech (M) Sdn Bhd Full time

    **Job Summary**: The Regulatory Affairs and Quality Control Executive plays a crucial role in supporting the Regulatory Affairs and Quality Control Manager in ensuring compliance with regulatory standards and maintaining high-quality product standards. This position involves active participation in product registration activities, quality control processes,...


  • Shah Alam, Malaysia Eternity Healthcare Sdn Bhd Full time

    _**Regulatory**_ 1. Responsible for all regulatory affairs, regulatory compliance activities and submission of medical device products of the company. 2. Review, prepare, compile and submit all documentations required for medical device submission, establishment license renewal, new devices registration, change notification and special access with...


  • Shah Alam, Selangor, Malaysia EPS Ventures Sdn Bhd Full time

    Key Responsibilities:1. Regulatory services & Pharmacovigilance & handling of controlled drug Review and approve marketing and promotion materials. Handle registration and maintain database of sales and advertisement permits issued by relevant authority bodies. Responsible for the Regulatory Affairs (RA) functions and team members. Provide leadership and...


  • Shah Alam, Selangor, Malaysia EPS Ventures Sdn Bhd Full time

    Key Responsibilities:1. Regulatory services & Pharmacovigilance & handling of controlled drug Review and approve marketing and promotion materials. Handle registration and maintain database of sales and advertisement permits issued by relevant authority bodies. Responsible for the Regulatory Affairs (RA) functions and team members. Provide leadership and...


  • Shah Alam, Selangor, Malaysia White Umbrella Sdn Bhd Full time

    As a Regulatory Affairs Executive for White Umbrella Sdn Bhd, your exciting yet challenging job descriptions are as below; Understanding regulations in regards to importation and distribution of medical devices, SIRIM registration and Suruhanjaya Tenaga Malaysia. Maintain an uptodate information on regulatory requirements and regulations. Liase with external...


  • Shah Alam, Selangor, Malaysia Eternity Healthcare Sdn Bhd Full time

    _Regulatory_Responsible for all regulatory affairs, regulatory compliance activities and submission of medical device products of the company.Review, prepare, compile and submit all documentations required for medical device submission, establishment license renewal, new devices registration, change notification and special access with media.Work closely...


  • Shah Alam, Selangor, Malaysia Medi Lifesports (M) Sdn Bhd Full time

    We are looking for a reliable Office Administrator for Regulatory Affairs Department. They will undertake administrative tasks, specifically assisting for preparing documents for product registration. To prepare and compile required documents for product registration. To follow through with subsequent correspondence until approval. To assist in preparing the...

  • Product Specialist

    4 weeks ago


    Shah Alam, Malaysia Thermo Fisher Scientific Full time

    **Product Specialist (Life Science Consumables)** When you are a part of the team at Thermo Fisher Scientific, you will do important work. Surrounded by collaborative colleagues, you will have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond....

  • Product Specialist

    2 weeks ago


    Shah Alam, Selangor, Malaysia Thermo Fisher Scientific Full time

    Product Specialist (Life Science Consumables)When you are a part of the team at Thermo Fisher Scientific, you will do important work. Surrounded by collaborative colleagues, you will have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take...


  • Shah Alam, Malaysia AVISENA HEALTHCARE SDN. BHD. Full time

    **Position Summary**: Responsible for the administration of the medical affairs function in managing medical practitioners' matters and provide support in clinical governance. **STANDARD PERFORMANCE**: - Demonstrate consistency with Avisena's mission and values. - Commit to fully comply with Avisena's Standard professional code of conduct and...


  • Shah Alam, Selangor, Malaysia AVISENA HEALTHCARE SDN. BHD. Full time

    Position Summary:Responsible for the administration of the medical affairs function in managing medical practitioners' matters and provide support in clinical governance.STANDARD PERFORMANCE: Demonstrate consistency with Avisena's mission and values. Commit to fully comply with Avisena's Standard professional code of conduct and Organizational Policies and...

  • QA/qc Manager

    4 weeks ago


    Shah Alam, Malaysia Brenntag Full time

    **QA/QC MANAGER**: Our team in **Shah Alam** currently has an opening for a **QA/QC Manager** **YOUR ROLE & RESPONSIBILITIES**: - Plan and execute Brenntag’s QSHE and Regulatory Affairs Processes - Develop and maintain relationship with relevant internal and external parties to expedite the registration process - Provide regulatory inputs to support...


  • Shah Alam, Malaysia Brenntag Full time

    **PLANNING AND PROCUREMENT SPECIALIST**: Our team in **Shah Alam** currently has an opening for a **Planning and Procurement Specialist** **YOUR ROLE & RESPONSIBILITIES**: - Handling purchase order processing and coordinating local, import and export shipments. - Preparing shipping documents for the import/export shipments (Invoice/ Packing...

  • Hse Specialist

    4 weeks ago


    Shah Alam, Malaysia Rotork Full time

    **Company Description** Rotork is the market-leading global flow control and instrumentation company, helping our customers manage the flow or liquids, gases and powders across many industries worldwide. Our purpose is Keeping the World Flowing for Future Generations. For over sixty years, the world has relied on us to create the things that keep...

  • QA Officer

    4 weeks ago


    Shah Alam, Malaysia Ritamix Sdn Bhd Full time

    **Job Descriptions**: - Provide nutritional consultation and handle related product enquiries - Assist in new and existing product labelling requirement - Prepare product presentation, product information, articles or any support materials for marketing purposes. - Conduct and review local and oversea relevant HACCP & GMP procedures. - Responsible for...


  • Shah Alam, Malaysia KuchingJobs Full time

    **Working Days & Hours** - Working Hours: From 8.30am to 5.45pm - Work Days: Monday to Friday only** **Benefits & Remunerations** - Salary Range: RM 2500 to RM 3500 - EPF, SOCSO & EIS - Medical & Annual Leave **Job Requirements** - At least 2 years working experience is required in manufacturing field - Experience in Health Food formulation and R&D of...


  • Shah Alam, Selangor, Malaysia KuchingJobs Full time

    Working Days & Hours Working Hours: From 8.30am to 5.45pm Work Days: Monday to Friday only**Benefits & Remunerations Salary Range: RM 2500 to RM 3500 EPF, SOCSO & EIS Medical & Annual LeaveJob Requirements At least 2 years working experience is required in manufacturing field Experience in Health Food formulation and R&D of supplements Selfmotivated and able...

  • DevOps Specialist

    2 weeks ago


    Shah Alam, Selangor, Malaysia Talent Houz Consulting & Services Full time

    Job Title: DevOps SpecialistIndustry: IT SolutionLocation: Within KLSalary Range: RM5000-RM9000Responsibilities: Implement scalability and performance optimization strategies, including capacity planning and performance tuning of a largescale deployment. Implement, configure, and manage Kafka and AMQ (ActiveMQ) to facilitate efficient and reliable message...