Regulatory Affairs Pharmacist

1 week ago


Setia Alam, Malaysia Trent Pharma Sdn Bhd Full time

New product registration and regulatory filling plan for OEM Products including pharmaceutical products, medical devices, FMCG, etc. (MAL, MDA NOT and Food), in Southeast Asian countries.
- Functional regulatory representative of the OEM Products manufactured by third-party (OEM) manufacturers to support regulatory submission and approval.
- Coordinated and ensured products approval in SEA countries.
- Product commercial supply, i.e., custom importation, clearance requirement, etc.
- Conducted dossier gap analysis and provided relevant regulatory advice by comparing the local dossier versus the latest ICH/ASEAN & other applicable Guidelines.
- Cosmetic GMP, GDPMD, ISO 13485 licensing establishment.

Job requirements:
**Requirements**:

- At least 3 year working experience in product submission and registration of schedule poison, OTC, health supplement or traditional medicine with NPRA.

**Salary**: RM4,000.00 - RM5,000.00 per month

**Benefits**:

- Flexible schedule
- Opportunities for promotion
- Professional development

Schedule:

- Flexible hours

Supplemental pay types:

- Performance bonus



  • Shah Alam, Malaysia EON PARTNERS Full time

    **REGULATORY AFFAIRS EXECUTIVE** *** The Regulatory Executive manages product and company license renewals with government agencies and ensures compliance with local laws and regulations. The role also monitors regulatory changes and updates management to prevent business risks. **RESPONSIBILITIES** **1. Regulatory Affairs & Compliance** - Prepare,...


  • Shah Alam, Malaysia Malaysian Healthcare Sdn Bhd Full time

    Responsibilities: - To fully assist in product (medical device) registration and regulatory compliance with relevant government bodies for group of companies - To assist in implementation of ISO and GDPMD standard for group of companies - To assist in all administration jobs related to the regulatory affairs and quality assurance matters - Oversee...


  • 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, Selangor, Malaysia Bits Medical Sdn Bhd Full time

    Responsibilities: -Assist in ensuring company compliance with Medical Device Authority (MDA) requirements.Support in Establishment Licensing and Medical Device Registration matters.Liaise with overseas manufacturers for regulatory documentation.Assist in the renewal of certificates and licenses accurately and on time.Maintain and update regulatory records...


  • Shah Alam, Malaysia Clinigen Full time

    Link, part of the Clinigen Group, is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, UK and EU, Asia Pacific and South Africa. We're growing rapidly and well positioned...

  • Regulatory Manager

    1 week ago


    Shah Alam, Selangor, Malaysia DCH Auriga (Malaysia) Sdn Bhd Full time

    1. Regulatory services & Pharmacovigilance & handling of controlled drug- Review and approve marketing and promotional materials to ensure compliance with relevant guidelines and standards.- Manage registration processes and maintain an up-to-date database of sales and advertising permits issued by the appropriate regulatory authorities.- Responsible for...


  • Shah Alam, Malaysia AP ExecSearch SDN BHD Full time

    Location : Seksyen U1, Shah Alam Salary : RM 3,500 - 5,500 **Key** Responsibilities**: - Responsible for the regulatory and compliance requirements for the products under the group of companies. - Ensure regulatory compliance by proactively monitoring, interpreting, implementing and conveying global and regional regulations that impact products and local...


  • Shah Alam, Selangor, Malaysia Fraser & Neave Holdings Bhd (F&N) Full time

    Job Purpose1.To provides regulatory, scientific and nutrition support to the business unit.2.The incumbent keeps abreast of local & oversea countries regulatory knowledge.Key Accountabilities1.Ensure raw material, product recipe / formulation, label and communication material compliance to the regulatory requirement of Malaysia, Brunei and other markets as...


  • Shah Alam, Malaysia INTEGRASI GLOBAL SDN. BHD. Full time

    Responsible for product registration of cosmetic and personal care by NPRA - Prepare documentations for GMP, HALAL and ISO 9001 audit - Maintained departmental quality documents (standard operation procedure, working instructions, etc) to ensure comply with regulations set by GMP, HALAL and recognition set by ISO certification. - Responsible for internal...


  • Setia Alam, Malaysia TERAJU PHARMA SDN BHD Full time

    **Open for Central Malaysia region.** The Professional Medical Representative plays a vital role in promoting and selling pharmaceutical products to healthcare professionals. This position involves building strong relationships with customers, providing product information, and driving sales within the assigned territory. As Professional Medical...