Product Submissions Specialist – Regulatory Affairs

MNC JOBS INFO; Singapore; Hybrid; SGD 50,000 - 75,000; Full time

Benefits offered by this job

Hybrid or remote work flexibility

Job summary

MNC JOBS INFO is actively seeking a Regulatory Affairs Associate – Product Submission Support to assist with regulatory documentation, product registrations, and submission preparation. The role involves collaboration with Regulatory Affairs, QA, R&D, and Manufacturing to ensure complete and compliant submission materials.

The candidate should have a strong eye for detail, effective communication, and willingness to learn evolving regulatory standards across regulated industries.

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, Biology, Medical Sciences, or related discipline preferred.
• Regulatory documentation, quality assurance, clinical research, or pharmaceutical administration experience may be considered.
• Basic understanding of regulatory affairs principles and product registration processes.
• Familiarity with regulatory documentation, technical files, product dossiers, and submission checklists is an advantage.
• Strong written and verbal communication skills; excellent attention to detail.
• Good organizational skills; able to manage multiple documents and deadlines.
• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and common document management tools.
• Ability to maintain accurate records and follow established documentation procedures.
• Strong problem-solving skills; ability to identify missing or incomplete information.
• Ability to collaborate with cross-functional teams and communicate professionally.

Responsibilities

• Assist in preparing and compiling regulatory submission packages for new products, registrations, renewals, variations, and post-approval changes.
• Collect, organize, format, and review regulatory documents, including forms, product information, technical reports, certificates, and declarations.
• Maintain submission checklists and verify documents, signatures, approvals, and supporting materials before submission.
• Support compliance with regulatory guidelines, internal procedures, and submission requirements.
• Review documents for completeness, consistency, correct versions, formatting, and alignment with internal information.
• Coordinate with internal teams to obtain missing information and resolve documentation discrepancies.
• Update regulatory trackers, submission logs, product records, and document management systems.
• Monitor submission timelines, milestones, deadlines, and regulatory progress; escalate delays as needed.
• Assist with electronic submission: file organization, naming conventions, and compatibility checks.
• Help organize communications with regulatory authorities and prepare responses to information requests and deficiencies.
• Track product approvals, renewals, labeling updates, and post-approval regulatory commitments.
• Follow SOPs, document control processes, and quality management requirements.
• Maintain organized records for audits and compliance reviews.
• Handle confidential information responsibly in line with policies.
• Identify opportunities to improve document organization and submission workflows.

Skills

Regulatory knowledge

Documentation skills

Attention to detail

Communication

Organizational skills

Cross-functional teamwork

Regulatory submission procedures

Problem solving

Education

Bachelor's degree in Pharmacy/related field

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Document management tools

Job description

MNC JOBS INFO is actively seeking a Regulatory Affairs Associate – Product Submission Support to assist with regulatory documentation, product registrations, and submission preparation. The role involves collaboration with Regulatory Affairs, QA, R&D, and Manufacturing to ensure complete and compliant submission materials.

The candidate should have a strong eye for detail, effective communication, and willingness to learn evolving regulatory standards across regulated industries.