Regulatory Affairs & Submission Specialist

SYNER RV SDN BHD; Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

SYNER RV SDN BHD in Kuala Lumpur is seeking an experienced Regulatory Affairs & Submission Specialist to prepare, coordinate and submit regulatory dossiers for pharmaceutical products to NPRA.

The ideal candidate has 3+ years in regulatory affairs, hands‑on NPRA submissions and ASEAN CTD/ACTD experience, with strong English and Bahasa Melayu and solid document management skills.

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Science, Biotechnology, Biomedical Science or an equivalent science-related discipline.
• Minimum 3 years of relevant working experience in Regulatory Affairs, specifically pharmaceutical dossier preparation and filing.
• Hands-on experience with pharmaceutical product registration submissions is essential.
• Experience dealing with NPRA Malaysia regulatory submissions is highly preferred.
• Experience in preparing or reviewing ASEAN CTD (ACTD) / CTD dossiers.
• Good understanding of pharmaceutical registration requirements and regulatory documentation.
• Strong written and spoken English & Bahasa Melayu.
• Good command of Microsoft Office, particularly Word, Excel and PowerPoint.

Responsibilities

• Prepare, compile, review and submit regulatory dossiers for pharmaceutical products to NPRA.
• Coordinate preparation of ASEAN CTD (ACTD) / CTD dossiers, including administrative and technical documentation.
• Ensure dossiers are complete, accurate, properly formatted and submitted within agreed timelines.
• Manage regulatory submissions through the relevant QUEST 3+ processes.
• Prepare and coordinate submissions for new product registrations, product variations / amendments, product renewals, re‑registration and post‑registration activities, and other regulatory applications as required.
• Review regulatory documents and identify missing, incomplete or inconsistent information before submission.
• Coordinate with internal departments including Quality Assurance, Quality Control, R&D, Medical, Supply Chain, Manufacturing and Commercial teams to obtain required regulatory documents.
• Liaise with overseas manufacturers, principals, suppliers and regulatory teams to obtain technical and regulatory documentation.
• Respond to NPRA queries and coordinate the preparation of responses and additional documents requested by the authority.
• Monitor submission status, regulatory timelines and approval progress.

Skills

Regulatory affairs

Dossier preparation

Documentation management

English & Bahasa Melayu

Education

Bachelor's degree in Pharmacy/Pharmaceutical Science

Tools

Microsoft Office

Job description

Regulatory Affairs & Submission Specialist

We are looking for an experienced and detail-oriented Regulatory Affairs & Submission Specialist to join our team. The successful candidate will be responsible for preparing, coordinating and submitting regulatory dossiers for pharmaceutical products, ensuring that all submissions comply with applicable Malaysian regulatory requirements and company procedures. This role is ideal for a regulatory affairs professional with at least 3 years of hands‑on experience in pharmaceutical dossier preparation and filing, particularly with NPRA submissions, ASEAN CTD/ACTD documentation and post‑registration regulatory activities.

Key responsibilities

• Prepare, compile, review and submit regulatory dossiers for pharmaceutical products to NPRA.
• Coordinate preparation of ASEAN CTD (ACTD) / CTD dossiers, including administrative and technical documentation.
• Ensure dossiers are complete, accurate, properly formatted and submitted within agreed timelines.
• Manage regulatory submissions through the relevant QUEST 3+ processes.
• Prepare and coordinate submissions for new product registrations, product variations / amendments, product renewals, re‑registration and post‑registration activities, and other regulatory applications as required.
• Review regulatory documents and identify missing, incomplete or inconsistent information before submission.
• Coordinate with internal departments including Quality Assurance, Quality Control, R&D, Medical, Supply Chain, Manufacturing and Commercial teams to obtain required regulatory documents.
• Liaise with overseas manufacturers, principals, suppliers and regulatory teams to obtain technical and regulatory documentation.
• Respond to NPRA queries and coordinate the preparation of responses and additional documents requested by the authority.
• Monitor submission status, regulatory timelines and approval progress.

About you

Bachelor's Degree in Pharmacy, Pharmaceutical Science, Biotechnology, Biomedical Science or an equivalent science-related discipline.

Minimum 3 years of relevant working experience in Regulatory Affairs, specifically pharmaceutical dossier preparation and filing.

Hands‑on experience with pharmaceutical product registration submissions is essential.

Experience dealing with NPRA Malaysia regulatory submissions is highly preferred.

Experience in preparing or reviewing ASEAN CTD (ACTD) / CTD dossiers.

Good understanding of pharmaceutical registration requirements and regulatory documentation.

Strong written and spoken English & Bahasa Melayu.

Good command of Microsoft Office, particularly Word, Excel and PowerPoint.

Excellent attention to detail, strong document management skills, and good analytical and problem‑solving ability.

Excellent organizational and time‑management skills with ability to manage multiple submissions simultaneously.

Preferred / Added Advantages
Direct experience submitting pharmaceutical products to NPRA Malaysia.