Regulatory Affairs Associate – Product Submission Support

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

Job Summary

MNC JOBS INFO is seeking a detail-oriented and organized Regulatory Affairs Associate – Product Submission Support to assist with regulatory documentation, product registration activities, submission preparation, and compliance-related administrative processes. This role is ideal for candidates interested in pharmaceutical regulations, medical devices, biotechnology, healthcare products, or other regulated industries.

The successful candidate will support the preparation, review, compilation, and maintenance of regulatory submission documents required for product approvals, registrations, variations, renewals, and other regulatory procedures. Working closely with Regulatory Affairs, Quality Assurance, Research and Development, Manufacturing, and other cross-functional teams, the associate will help ensure that submission materials are complete, accurate, properly organized, and prepared according to applicable regulatory requirements.

The role requires strong documentation skills, attention to detail, effective communication, and a willingness to learn evolving regulatory standards. Candidates who enjoy working with technical documents, coordinating information, and maintaining accurate records are encouraged to apply.

Key Responsibilities

• Regulatory Submission Support: Assist in preparing and compiling regulatory submission packages for new products, existing product registrations, renewals, variations, and post-approval changes.
• Documentation Preparation: Collect, organize, format, and review regulatory documents, including application forms, product information, technical reports, certificates, declarations, and supporting records.
• Submission Checklist Management: Maintain submission checklists and verify that required documents, signatures, approvals, and supporting materials are available before submission.
• Regulatory Compliance: Support compliance with applicable regulatory guidelines, internal procedures, documentation standards, and submission requirements established by relevant health authorities.
• Document Quality Checks: Review documents for completeness, consistency, correct version numbers, formatting, and alignment with approved internal information.
• Cross-Functional Coordination: Communicate with internal teams to obtain missing information, clarify documentation discrepancies, and follow up on outstanding submission requirements.
• Regulatory Database Maintenance: Update regulatory trackers, submission logs, product registration records, approval databases, and document management systems.
• Submission Tracking: Monitor submission timelines, internal milestones, document collection deadlines, and regulatory review progress. Escalate potential delays to the appropriate team members.
• Electronic Submission Support: Assist with preparing electronic files, organizing submission folders, applying naming conventions, and checking documents for compatibility with the applicable submission format.
• Regulatory Correspondence: Help organize communications with regulatory authorities and support the preparation of responses to information requests, deficiency notices, and clarification questions under appropriate supervision.
• Product Lifecycle Support: Assist with tracking product approvals, registration renewals, labeling updates, safety-related documentation, and post-approval regulatory commitments.
• Standard Operating Procedures: Follow established standard operating procedures (SOPs), document control processes, and quality management requirements.
• Audit Readiness: Maintain organized and traceable records to support internal audits, regulatory inspections, and compliance reviews.
• Confidentiality: Handle sensitive product information, technical documentation, and company records responsibly and in accordance with applicable confidentiality policies.
• Process Improvement: Identify opportunities to improve document organization, tracking systems, submission workflows, and administrative efficiency.

Required Skills and Qualifications

• A bachelors degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, Biology, Medical Sciences, or a related discipline is preferred.
• Candidates with relevant education or experience in regulatory documentation, quality assurance, clinical research, or pharmaceutical administration may also be considered, depending on the position requirements.
• 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 and accuracy when reviewing technical information.
• Good organizational skills and the ability 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 and the ability to identify missing, inconsistent, or incomplete information.
• Ability to collaborate with cross-functional teams and communicate professionally.
• Willingness to learn regulatory requirements and adapt to changing procedures.
• A responsible approach to confidential information and regulated documentation.

Experience

Candidates with varying levels of experience may be considered according to the specific vacancy and business requirements.

Entry‑Level Candidates

Fresh graduates with relevant academic qualifications and a strong interest in regulatory affairs are encouraged to apply where training is available. A basic understanding of pharmaceutical documentation, quality systems, or healthcare regulations is beneficial.

Experienced Candidates

Applicants with approximately 1–3 years of experience in regulatory affairs, product registration, regulatory operations, quality assurance, pharmaceutical documentation, or related administrative roles may be preferred for positions requiring prior experience.

Experience with the following activities will be an advantage:

• Preparing and maintaining regulatory submission documents.
• Supporting product registration, renewal, or variation applications.
• Maintaining regulatory trackers and document repositories.
• Reviewing technical documents for completeness and consistency.
• Working with electronic document management systems.
• Supporting regulatory audits, inspections, or authority correspondence.
• Following document control procedures and quality management systems.

Experience requirements may vary depending on the product category, jurisdiction, and level of responsibility.

Working Hours

Job Type: Full-time, subject to the specific vacancy.

Working Schedule: Generally, 8 hours per day, five days per week, depending on the employers operational requirements.

Work Arrangement: On-site, hybrid, or remote options may be available for eligible positions, depending on company policy and the nature of the work.

Shift Requirements: Standard business hours are typical, although occasional flexibility may be required to meet submission deadlines or coordinate with international teams.

Deadline Management: Employees are expected to plan their work effectively and prioritize time‑sensitive regulatory activities.

Additional Hours: Occasional additional hours may be required during critical submission periods, subject to applicable policies.

Final working hours, location, employment type, and shift arrangements will be confirmed during the recruitment process.

Knowledge, Skills, and Abilities

Regulatory Knowledge

Basic understanding of regulatory affairs functions and product approval pathways.

Awareness of the importance of regulatory compliance in pharmaceutical, biotechnology, medical device, or healthcare-related industries.

Familiarity with the purpose of product dossiers, technical documentation, certificates, labeling information, and regulatory application forms.

Willingness to learn applicable regulatory frameworks and guidance issued by relevant authorities.

Documentation and Technical Skills

Ability to prepare, format, organize, and verify documents according to established requirements.

Familiarity with document version control, naming conventions, record retention, and traceability.

Ability to maintain structured digital folders and electronic submission records.

Basic spreadsheet skills for submission tracking, status reporting, and deadline monitoring.

Analytical and Organizational Abilities

Ability to identify missing information, discrepancies, and inconsistencies in documents.

Strong planning skills and the ability to manage multiple priorities.

Capacity to follow detailed instructions and established procedures.

Ability to maintain accuracy when handling repetitive and time‑sensitive tasks.

Communication and Teamwork

Professional communication with internal stakeholders.

Ability to request information, follow up on pending documents, and report progress clearly.

Willingness to work collaboratively with regulatory, quality, technical, and operational teams.

Ability to receive feedback and apply corrections promptly.

Professional Attributes

Integrity, reliability, accountability, and a strong sense of responsibility.

Commitment to confidentiality and data integrity.

A proactive attitude toward learning and professional development.

Flexibility in responding to changing priorities and regulatory requirements.

Benefits

• Competitive salary based on qualifications, experience, and role responsibilities.
• Structured onboarding and opportunities for job‑related training.
• Exposure to regulatory submission processes and product lifecycle management.
• Opportunities to develop regulatory documentation and compliance skills.
• Professional development support and access to relevant learning resources.
• Collaborative work with experienced regulatory and quality professionals.
• Potential hybrid or remote work flexibility where the role permits.
• Paid leave and applicable employee benefits in accordance with company policy.
• Performance‑based recognition or career advancement opportunities, where offered.
• Opportunities to build experience in pharmaceutical, biotechnology, medical device, and healthcare regulatory operations.

Note: Benefits, compensation, training arrangements, and remote‑work options depend on the actual employer, employment contract, and applicable policies. They should be confirmed with the recruiter.

Why Join MNC JOBS INFO?

Joining a regulatory affairs team can be a valuable step for candidates who want to build a career in regulated industries and contribute to the accurate preparation of product approval documentation.

As a Regulatory Affairs Associate – Product Submission Support, you can develop practical knowledge of regulatory processes, document management, compliance requirements, and cross‑functional coordination. The position provides an opportunity to strengthen analytical skills while learning how regulatory documentation supports product quality, safety, and lawful market access.

Potential career development pathways may include:

• Regulatory Affairs Associate
• Regulatory Submission Specialist
• Regulatory Operations Analyst
• Product Registration Specialist
• Regulatory Documentation Specialist
• Regulatory Affairs Executive
• Senior Regulatory Affairs Associate
• Regulatory Affairs Manager, with suitable experience and qualifications

Career progression will depend on individual performance, additional training, professional qualifications, and available opportunities.

Candidates who are detail‑oriented, organized, eager to learn, and interested in pharmaceutical or healthcare compliance are encouraged to explore this opportunity.